Radio frequency energy device for delivering combined electrical signals

ABSTRACT

An electrosurgical device may include a controller including an electrical generator, a surgical probe having a distal active electrode in electrical communication with an electrical source terminal of the electrical generator, and a return pad in electrical communication with an electrical return terminal of the electrical generator. The electrical generator may be configured to source an electrical current from the electrical source terminal, in which the electrical current combines characteristics of a therapeutic electrical signal and characteristics of an excitable tissue stimulating signal. The device may be configured to determine a distance from the electrode to an excitable tissue, based at least in part on an output signal generated by a sensing device in the pad. The device may also be configured to alter one or more characteristics of the therapeutic signal when the distance from the electrode to the tissue is less than a predetermined value.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,995, titled CONTROLLING ANULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION, filed onAug. 23, 2018, the disclosure of which is herein incorporated byreference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,998, titled SITUATIONALAWARENESS OF ELECTROSURGICAL SYSTEMS, filed on Aug. 23, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,999, titled INTERRUPTION OFENERGY DUE TO INADVERTENT CAPACITIVE COUPLING, filed on Aug. 23, 2018,the disclosure of which is herein incorporated by reference in itsentirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,994, titled BIPOLARCOMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON ENERGYMODALITY, filed on Aug. 23, 2018, the disclosure of which is hereinincorporated by reference in its entirety.

The present application claims priority under 35 U.S.C. § 119(e) to U.S.Provisional Patent Application No. 62/721,996, titled RADIO FREQUENCYENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL SIGNALS, filed on Aug.23, 2018, the disclosure of which is herein incorporated by reference inits entirety.

The present application also claims priority under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 62/692,747, titled SMARTACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE, filed on Jun. 30,2018, to U.S. Provisional Patent Application No. 62/692,748, titledSMART ENERGY ARCHITECTURE, filed on Jun. 30, 2018, and to U.S.Provisional Patent Application No. 62/692,768, titled SMART ENERGYDEVICES, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/640,417,titled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR, filed Mar. 8, 2018, and to U.S. Provisional Patent ApplicationSer. No. 62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTORAND CONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, the disclosure of eachof which is herein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/650,898 filed onMar. 30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLEARRAY ELEMENTS, to U.S. Provisional Patent Application Ser. No.62/650,887, titled SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES,filed Mar. 30, 2018, to U.S. Provisional Patent Application Ser. No.62/650,882, titled SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICALPLATFORM, filed Mar. 30, 2018, and to U.S. Provisional PatentApplication Ser. No. 62/650,877, titled SURGICAL SMOKE EVACUATIONSENSING AND CONTROLS, filed Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S.Provisional Patent Application Ser. No. 62/611,340, titled CLOUD-BASEDMEDICAL ANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

In some surgical procedures, a medical professional may employ anelectrosurgical device to seal or cut tissues such as blood vessels.Such devices effect a medical therapy by passing electrical energy, forexample current at radiofrequencies (RF), through the tissue to betreated. Some electrosurgical devices are termed bipolar devices in thatboth an electrode to source the electrical energy (the active electrode)and a return electrode are housed in the same surgical probe. Theelectrosurgical device may include a generator to generate theelectrical energy and supply the electrical energy to the activeelectrode in the surgical probe. The return electrode in the surgicalprobe may receive the current flowing through the patient's tissue andprovide an electrical return path to the generator. Such bipolar devicesmay provide a short current path through the patient's tissue, and themedical professional can readily determine the tissues that may receivethe electrical energy from the electrosurgical device.

Alternative devices may be termed monopolar devices. In such devices,only the active electrode is housed in the surgical probe. Theelectrical current entering the patient's tissue may return to theelectrical energy generator via an electrical path through the gurney onwhich the patient reposes or through a specific return electrode pad. Insome aspects, the patient may repose on the electrode pad, or theelectrode pad may be placed on the patient at a location close to thesurgical site where the surgical probe is deployed. It may be recognizedthat the current path through a patient undergoing a procedure using amonopolar device may be less well characterized than the current paththrough a patient undergoing a procedure using a bipolar device.Consequently, some non-target tissue may be inadvertently cauterized,cut, or otherwise damaged by a monopolar electrosurgical device. Suchnon-target tissue may include electrically excitable tissue including,without limitation, ganglia, sensory nervous tissue, motor nervoustissue, and muscle tissue. Such unintended injury to excitable tissuemay result in the patient experiencing muscle weakness, pain, numbness,paralysis and/or other undesired outcomes.

SUMMARY

In an aspect, an electrosurgical device includes a controller having anelectrical generator, a surgical probe including a distal activeelectrode, in which the active electrode is in electrical communicationwith an electrical source terminal of the electrical generator, and areturn pad in electrical communication with an electrical returnterminal of the electrical generator. The electrical generator isconfigured to source an electrical current from the electrical sourceterminal, and the electrical current sourced by the electrical generatorcombines characteristics of a therapeutic electrical signal andcharacteristics of an excitable tissue stimulating signal.

In one aspect of the electrosurgical device, the therapeutic electricalsignal is a radiofrequency signal having a frequency greater than 200kHz and less than 5 MHz.

In one aspect of the electrosurgical device, the excitable tissuestimulating signal is an AC signal having a frequency less than 200 kHz.

In one aspect of the electrosurgical device, the electrical currentsourced by the electrical generator includes at least one alternatingtherapeutic electrical signal and at least one alternating excitabletissue stimulating signal.

In one aspect of the electrosurgical device, the electrical currentsourced by the electrical generator includes a therapeutic electricalsignal amplitude modulated by the excitable tissue stimulating signal.

In one aspect of the electrosurgical device, the electrical currentsourced by the electrical generator includes a therapeutic electricalsignal DC offset by the excitable tissue stimulating signal.

In one aspect of the electrosurgical device, the return pad furtherincludes at least one sensing device having a sensing device output, andthe sensing device is configured to determine a stimulation of anexcitable tissue by the excitable tissue stimulating signal.

In one aspect of the electrosurgical device, the controller isconfigured to receive the sensing device output.

In one aspect of the electrosurgical device, the controller includes aprocessor and at least one memory component in data communication withthe processor, in which the at least one memory component stores one ormore instructions that, when executed by the processor, cause theprocessor to determine a distance of the active electrode from anexcitable tissue based at least in part on the sensor output received bythe controller.

In one aspect of the electrosurgical device, the at least one memorycomponent stores one or more instructions that, when executed by theprocessor, cause the processor to alter a value of at least onecharacteristic of the therapeutic electrical signal when the distance ofthe active electrode from an excitable tissue is less than apredetermined value.

In an aspect, an electrosurgical system includes a processor and amemory coupled to the processor, in which the memory is configured tostore instructions executable by the processor to cause an electricalgenerator to combine one or more characteristics of a therapeutic signalwith one or more characteristics of an excitable tissue stimulatingsignal to form a combination signal, cause the electrical generator totransmit the combination signal into a tissue of a patient through anactive electrode in physical contact with the patient, and receive asensing device output signal from a sensing device disposed within areturn pad in physical contact with the patient.

In one aspect of the electrosurgical system, the memory is configured tofurther store instructions executable by the processor to determine,based at least in part on the sensing device output signal, a distancefrom the active electrode to an excitable tissue.

In one aspect of the electrosurgical system, the memory is configured tofurther store instructions executable by the processor to cause thecontroller to alter one or more characteristics of the therapeuticsignal when the distance from the active electrode to the excitabletissue is less than a predetermined value.

In one aspect of the electrosurgical system, the instructions executableby the processor to cause an electrical generator to combine one or morecharacteristics of a therapeutic signal with one or more characteristicsof an excitable tissue stimulating signal to form a combination signalincludes instructions executable by the processor to cause theelectrical generator to alternate the therapeutic signal and theexcitable tissue stimulating signal.

In one aspect of the electrosurgical system, the instructions executableby the processor to cause an electrical generator to combine one or morecharacteristics of a therapeutic signal with one or more characteristicsof an excitable tissue stimulating signal to form a combination signalincludes instructions executable by the processor to cause theelectrical generator to modulate an amplitude of the therapeutic signalby an amplitude of the excitable tissue stimulating signal.

In one aspect of the electrosurgical system, the instructions executableby the processor to cause an electrical generator to combine one or morecharacteristics of a therapeutic signal with one or more characteristicsof an excitable tissue stimulating signal to form a combination signalincludes instructions executable by the processor to cause theelectrical generator to offset a DC value of the therapeutic signal byan amplitude of the excitable tissue stimulating signal.

In an aspect, an electrosurgical system includes a control circuitconfigured to control an electrical output of an electrical generator,in which the electrical output includes one or more characteristics of atherapeutic signal and one or more characteristics of an excitabletissue stimulating signal, receive a sensing device signal from at leastone sensing device configured to measure an activity of an excitabletissue of a patient, determine a distance between a location of anactive electrode configured to transmit the electrical output of theelectrical generator into a patient tissue and a location of the atleast one sensing device, and alter the electrical output of theelectrical generator in at least one characteristic of the therapeuticsignal when the distance between the location of the active electrodeconfigured to transmit the electrical output of the electrical generatorinto the patient tissue and the location of the at least one sensingdevice is less than a pre-determined value.

In one aspect of the electrosurgical system, the control circuitconfigured to alter the electrical output of the electrical generator inat least one characteristic of the therapeutic signal when the distancebetween the location of the active electrode configured to transmit theelectrical output of the electrical generator into the patient tissueand the location of the at least one sensing device is less than apre-determined value includes a control circuit configured to minimizethe at least one characteristic of the therapeutic signal.

In an aspect, a non-transitory computer readable medium stores computerreadable instructions which, when executed, cause a machine to controlan electrical output of an electrical generator, in which the electricaloutput includes one or more characteristics of a therapeutic signal andone or more characteristics of an excitable tissue stimulating signal,receive a sensing device signal from at least one sensing deviceconfigured to measure an activity of an excitable tissue of a patient,determine a distance between a location of an active electrodeconfigured to transmit the electrical output of the electrical generatorinto a patient tissue and a location of the at least one sensing device,and alter the electrical output of the electrical generator in at leastone characteristic of the therapeutic signal when the distance betweenthe location of the active electrode configured to transmit theelectrical output of the electrical generator into the patient tissueand the location of the at least one sensing device is less than apre-determined value.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 7 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 8 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 9 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 10 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 11 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 12 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 13 is a system configured to execute adaptive ultrasonic bladecontrol algorithms in a surgical data network comprising a modularcommunication hub, in accordance with at least one aspect of the presentdisclosure.

FIG. 14 illustrates an example of a generator, in accordance with atleast one aspect of the present disclosure.

FIG. 15 is a surgical system comprising a generator and various surgicalinstruments usable therewith in accordance with at least one aspect ofthe present disclosure.

FIG. 16 is a diagram of the surgical system of FIG. 15 in accordancewith at least one aspect of the present disclosure.

FIG. 17 is a structural view of a generator architecture in accordancewith at least one aspect of the present disclosure.

FIGS. 18A-18C are functional views of a generator architecture inaccordance with at least one aspect of the present disclosure.

FIGS. 19A-19B are structural and functional aspects of a generator inaccordance with at least one aspect of the present disclosure.

FIG. 20 is a schematic diagram of a control circuit, in accordance withat least one aspect of the present disclosure.

FIG. 21 illustrates a generator circuit partitioned into multiplestages, in accordance with at least one aspect of the presentdisclosure.

FIG. 22 illustrates a generator circuit partitioned into multiple stageswhere a first stage circuit is common to the second stage circuit, inaccordance with at least one aspect of the present disclosure.

FIG. 23 is a schematic diagram of one aspect of a drive circuitconfigured for driving a high-frequency current (RF), in accordance withat least one aspect of the present disclosure.

FIG. 24 is a schematic diagram of the transformer coupled to the RFdrive circuit shown in FIG. 15, in accordance with at least one aspectof the present disclosure.

FIG. 25 is a schematic diagram of a circuit comprising separate powersources for high power energy/drive circuits and low power circuits, inaccordance with at least one aspect of the resent disclosure.

FIG. 26 illustrates a control circuit that allows a dual generatorsystem to switch between the RF generator and the ultrasonic generatorenergy modalities for a surgical instrument in accordance with at leastone aspect of the resent disclosure.

FIG. 27 illustrates one aspect of a fundamental architecture for adigital synthesis circuit such as a direct digital synthesis (DDS)circuit configured to generate a plurality of wave shapes for theelectrical signal waveform for use in a surgical instrument, inaccordance with at least one aspect of the present disclosure.

FIG. 28 illustrates one aspect of direct digital synthesis (DDS) circuitconfigured to generate a plurality of wave shapes for the electricalsignal waveform for use in surgical instrument, in accordance with atleast one aspect of the present disclosure.

FIG. 29 illustrates one cycle of a discrete time digital electricalsignal waveform, in accordance with at least one aspect of the presentdisclosure of an analog waveform (shown superimposed over a discretetime digital electrical signal waveform for comparison purposes), inaccordance with at least one aspect of the present disclosure.

FIG. 30 depicts a surgical procedure using an electrosurgical system inaccordance with at least one aspect of the present disclosure.

FIG. 31 illustrates a block diagram of the electrosurgical system usedin FIG. 30 in accordance with at least one aspect of the presentdisclosure.

FIG. 32 illustrates a return pad of the electrosurgical system of FIG.30 including a plurality of electrodes in accordance with at least oneaspect of the present disclosure.

FIG. 33 illustrates an array of sensing devices in the return paddepicted in FIG. 31 in accordance with at least one aspect of thepresent disclosure.

FIG. 34 is a graphical representation of a therapeutic RF signal thatmay be used in an electrosurgical system in accordance with at least oneaspect of the present disclosure.

FIG. 35 is a graphical representation of a nerve stimulation signal thatmay be incorporated in an electrosurgical system in accordance with atleast one aspect of the present disclosure.

FIGS. 36A-36C are graphical representations of signals used by anelectrosurgical system that may incorporate features of both thetherapeutic RF signal of FIG. 34 and the nerve stimulation signal ofFIG. 35 in accordance with at least one aspect of the presentdisclosure.

FIG. 37 summarizes a method in which such a control for a smartelectrosurgical device may be effected in accordance with at least oneaspect of the present disclosure.

FIG. 38 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 28, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/115,214, titled ESTIMATING        STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,        now U.S. Patent Application Publication No. 2019/0201073;    -   U.S. patent application Ser. No. 16/225,205, titled TEMPERATURE        CONTROL OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM THEREFOR,        now U.S. Patent Application Publication No. 2019/0201036;    -   U.S. patent application Ser. No. 16/225,208, titled CONTROLLING        AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO TISSUE LOCATION,        now U.S. Pat. No. 11,179,175;    -   U.S. patent application Ser. No. 16/115,220, titled CONTROLLING        ACTIVATION OF AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO THE        PRESENCE OF TISSUE, now U.S. Patent Application Publication No.        2019/0201040;    -   U.S. patent application Ser. No. 16/115,232, titled DETERMINING        TISSUE COMPOSITION VIA AN ULTRASONIC SYSTEM,, now U.S. Patent        Application Publication No. 2019/0201038;    -   U.S. patent application Ser. No. 16/115,239, titled DETERMINING        THE STATE OF AN ULTRASONIC ELECTROMECHANICAL SYSTEM ACCORDING TO        FREQUENCY SHIFT, now U.S. Patent Application Publication No.        2019/0201042;    -   U.S. patent application Ser. No. 16/115,247, titled DETERMINING        THE STATE OF AN ULTRASONIC END EFFECTOR, now U.S. Patent        Application Publication No. 2019/0274716;    -   U.S. patent application Ser. No. 16/115,211, titled SITUATIONAL        AWARENESS OF ELECTROSURGICAL SYSTEMS, now U.S. Patent        Application Publication No. 2019/0201039;    -   U.S. patent application Ser. No. 16/115,226, titled MECHANISMS        FOR CONTROLLING DIFFERENT ELECTROMECHANICAL SYSTEMS OF AN        ELECTROSURGICAL INSTRUMENT, now U.S. Patent Application        Publication No. 2019/0201075;    -   U.S. patent application Ser. No. 16/115,240, titled DETECTION OF        END EFFECTOR IMMERSION IN LIQUID, now U.S. Patent Application        Publication No. 2019/0201043;    -   U.S. patent application Ser. No. 16/115,249, titled INTERRUPTION        OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING, now U.S.        Patent Application Publication No. 2019/0201077;    -   U.S. patent application Ser. No. 16/115,256, titled INCREASING        RADIO FREQUENCY TO CREATE PAD-LESS MONOPOLAR LOOP, now U.S.        Patent Application Publication No. 2019/0201092;    -   U.S. patent application Ser. No. 16/115,223, titled BIPOLAR        COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE BASED ON        ENERGY MODALITY, now U.S. Pat. No. 11,147,607; and    -   U.S. patent application Ser. No. 16/115,238, titled ACTIVATION        OF ENERGY DEVICES, now U.S. Patent Application Publication No.        2019/0201041.

Applicant of the present application owns the following U.S. patentapplications, filed on Aug. 23, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/721,995, titled        CONTROLLING AN ULTRASONIC SURGICAL INSTRUMENT ACCORDING TO        TISSUE LOCATION;    -   U.S. Provisional Patent Application No. 62/721,998, titled        SITUATIONAL AWARENESS OF ELECTROSURGICAL SYSTEMS;    -   U.S. Provisional Patent Application No. 62/721,999, titled        INTERRUPTION OF ENERGY DUE TO INADVERTENT CAPACITIVE COUPLING;    -   U.S. Provisional Patent Application No. 62/721,994, titled        BIPOLAR COMBINATION DEVICE THAT AUTOMATICALLY ADJUSTS PRESSURE        BASED ON ENERGY MODALITY; and    -   U.S. Provisional Patent Application No. 62/721,996, titled RADIO        FREQUENCY ENERGY DEVICE FOR DELIVERING COMBINED ELECTRICAL        SIGNALS.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 30, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/692,747, titled SMART        ACTIVATION OF AN ENERGY DEVICE BY ANOTHER DEVICE;    -   U.S. Provisional Patent Application No. 62/692,748, titled SMART        ENERGY ARCHITECTURE; and    -   U.S. Provisional Patent Application No. 62/692,768, titled SMART        ENERGY DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 16/024,090, titled CAPACITIVE        COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS;    -   U.S. patent application Ser. No. 16/024,057, titled CONTROLLING        A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS;    -   U.S. patent application Ser. No. 16/024,067, titled SYSTEMS FOR        ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE        INFORMATION;    -   U.S. patent application Ser. No. 16/024,075, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,083, titled SAFETY        SYSTEMS FOR SMART POWERED SURGICAL STAPLING;    -   U.S. patent application Ser. No. 16/024,094, titled SURGICAL        SYSTEMS FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION        IRREGULARITIES;    -   U.S. patent application Ser. No. 16/024,138, titled SYSTEMS FOR        DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS        TISSUE;    -   U.S. patent application Ser. No. 16/024,150, titled SURGICAL        INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES;    -   U.S. patent application Ser. No. 16/024,160, titled VARIABLE        OUTPUT CARTRIDGE SENSOR ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,124, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. patent application Ser. No. 16/024,132, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE CIRCUIT;    -   U.S. patent application Ser. No. 16/024,141, titled SURGICAL        INSTRUMENT WITH A TISSUE MARKING ASSEMBLY;    -   U.S. patent application Ser. No. 16/024,162, titled SURGICAL        SYSTEMS WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES;    -   U.S. patent application Ser. No. 16/024,066, titled SURGICAL        EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. patent application Ser. No. 16/024,096, titled SURGICAL        EVACUATION SENSOR ARRANGEMENTS;    -   U.S. patent application Ser. No. 16/024,116, titled SURGICAL        EVACUATION FLOW PATHS;    -   U.S. patent application Ser. No. 16/024,149, titled SURGICAL        EVACUATION SENSING AND GENERATOR CONTROL;    -   U.S. patent application Ser. No. 16/024,180, titled SURGICAL        EVACUATION SENSING AND DISPLAY;    -   U.S. patent application Ser. No. 16/024,245, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. patent application Ser. No. 16/024,258, titled SMOKE        EVACUATION SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR        INTERACTIVE SURGICAL PLATFORM;    -   U.S. patent application Ser. No. 16/024,265, titled SURGICAL        EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION        BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE; and    -   U.S. patent application Ser. No. 16/024,273, titled DUAL        IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/691,228, titled        A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS        WITH ELECTROSURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/691,227, titled        CONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE        PARAMETERS;    -   U.S. Provisional Patent Application Ser. No. 62/691,230, titled        SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. Provisional Patent Application Ser. No. 62/691,219, titled        SURGICAL EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. Provisional Patent Application Ser. No. 62/691,257, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/691,262, titled        SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR        COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE;        and    -   U.S. Provisional Patent Application Ser. No. 62/691,251, titled        DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. ProvisionalPatent Application, filed on Apr. 19, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/659,900, titled        METHOD OF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/650,898 filed on Mar.        30, 2018, titled CAPACITIVE COUPLED RETURN PATH PAD WITH        SEPARABLE ARRAY ELEMENTS;    -   U.S. Provisional Patent Application No. 62/650,887, titled        SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;    -   U.S. Provisional Patent Application No. 62/650,882, titled SMOKE        EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and    -   U.S. Provisional Patent Application No. 62/650,877, titled        SURGICAL SMOKE EVACUATION SENSING AND CONTROLS

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING.    -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES.    -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application No. 62/649,294, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application No. 62/649,291, titled USE        OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application No. 62/649,315, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application No. 62/649,313, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application No. 62/649,320, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application No. 62/640,417, titled        TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM        THEREFOR; and    -   U.S. Provisional Patent Application No. 62/640,415, titled        ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM        THEREFOR.

Applicant of the present application owns the following U.S. ProvisionalPatent Applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Serial No. U.S. Provisional        Patent Application No. 62/611,341, titled INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application No. 62/611,340, titled        CLOUD-BASED MEDICAL ANALYTICS; and    -   U.S. Provisional Patent Application No. 62/611,339, titled ROBOT        ASSISTED SURGICAL PLATFORM.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Various aspects are directed to improved ultrasonic surgical devices,electrosurgical devices and generators for use therewith. Aspects of theultrasonic surgical devices can be configured for transecting and/orcoagulating tissue during surgical procedures, for example. Aspects ofthe electrosurgical devices can be configured for transecting,coagulating, scaling, welding and/or desiccating tissue during surgicalprocedures, for example.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 2 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application No. 62/611,339, titledROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure ofwhich is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application No. 62/611,340, titledCLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, the disclosure ofwhich is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope. Some aspects of spectraland multi-spectral imaging are described in greater detail under theheading “Advanced Imaging Acquisition Module” in U.S. Provisional PatentApplication No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filedDec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filedDec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety,for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, a storage array 134, and anoperating room mapping module 133. The generator module 140 can beconfigured to connect to a monopolar device 146, a bipolar device 147,and an ultrasonic device 148. In certain aspects, as illustrated in FIG.3, the hub 106 further includes a smoke evacuation module 126 and/or asuction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts,

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-5, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, each of which is herein incorporated byreference in its entirety.

FIG. 6 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 7 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 8, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 7, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 8 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 8, the modularcommunication hub 203 may be connected in a tiered configuration toexpand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 8, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filedDec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), E extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 8, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 7-8, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 9 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, in accordance with at least one aspect of thepresent disclosure. In the illustrated aspect, the USB network hubdevice 300 employs a TUSB2036 integrated circuit hub by TexasInstruments. The USB network hub 300 is a CMOS device that provides anupstream USB transceiver port 302 and up to three downstream USBtransceiver ports 304, 306, 308 in compliance with the USB 2.0specification. The upstream USB transceiver port 302 is a differentialroot data port comprising a differential data minus (DM0) input pairedwith a differential data plus (DP0) input. The three downstream USBtransceiver ports 304, 306, 308 are differential data ports where eachport includes differential data plus (DP1-DP3) outputs paired withdifferential data minus (DM1-DM3) outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware Control

FIG. 10 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool according to one aspect of thisdisclosure. The control circuit 500 can be configured to implementvarious processes described herein. The control circuit 500 may comprisea microcontroller comprising one or more processors 502 (e.g.,microprocessor, microcontroller) coupled to at least one memory circuit504. The memory circuit 504 stores machine-executable instructions that,when executed by the processor 502, cause the processor 502 to executemachine instructions to implement various processes described herein.The processor 502 may be any one of a number of single-core or multicoreprocessors known in the art. The memory circuit 504 may comprisevolatile and non-volatile storage media. The processor 502 may includean instruction processing unit 506 and an arithmetic unit 508. Theinstruction processing unit may be configured to receive instructionsfrom the memory circuit 504 of this disclosure. FIG. 11 illustrates acombinational logic circuit 510 configured to control aspects of thesurgical instrument or tool according to one aspect of this disclosure.The combinational logic circuit 510 can be configured to implementvarious processes described herein. The combinational logic circuit 510may comprise a finite state machine comprising a combinational logic 512configured to receive data associated with the surgical instrument ortool at an input 514, process the data by the combinational logic 512,and provide an output 516.

FIG. 12 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool according to one aspect ofthis disclosure. The sequential logic circuit 520 or the combinationallogic 522 can be configured to implement various processes describedherein. The sequential logic circuit 520 may comprise a finite statemachine. The sequential logic circuit 520 may comprise a combinationallogic 522, at least one memory circuit 524, and a clock 529, forexample. The at least one memory circuit 524 can store a current stateof the finite state machine. In certain instances, the sequential logiccircuit 520 may be synchronous or asynchronous. The combinational logic522 is configured to receive data associated with the surgicalinstrument or tool from an input 526, process the data by thecombinational logic 522, and provide an output 528. In other aspects,the circuit may comprise a combination of a processor (e.g., processor502, FIG. 10) and a finite state machine to implement various processesherein. In other aspects, the finite state machine may comprise acombination of a combinational logic circuit (e.g., combinational logiccircuit 510, FIG. 11) and the sequential logic circuit 520.

Generator Hardware

FIG. 13 is a system 800 configured to execute adaptive ultrasonic bladecontrol algorithms in a surgical data network comprising a modularcommunication hub, in accordance with at least one aspect of the presentdisclosure. In one aspect, the generator module 240 is configured toexecute one or more adaptive ultrasonic blade control algorithm(s). Inanother aspect, the device/instrument 235 is configured to execute theadaptive ultrasonic blade control algorithm(s). In another aspect, boththe device/instrument 235 and the device/instrument 235 are configuredto execute the adaptive ultrasonic blade control algorithms.

The generator module 240 may comprise a patient isolated stage incommunication with a non-isolated stage via a power transformer. Asecondary winding of the power transformer is contained in the isolatedstage and may comprise a tapped configuration (e.g., a center-tapped ora non-center-tapped configuration) to define drive signal outputs fordelivering drive signals to different surgical instruments, such as, forexample, an ultrasonic surgical instrument, an RF electrosurgicalinstrument, and a multifunction surgical instrument which includesultrasonic and RF energy modes that can be delivered alone orsimultaneously. In particular, the drive signal outputs may output anultrasonic drive signal (e.g., a 420V root-mean-square (RMS) drivesignal) to an ultrasonic surgical instrument 241, and the drive signaloutputs may output an RF electrosurgical drive signal (e.g., a 100V RMSdrive signal) to an RF electrosurgical instrument 241. Aspects of thegenerator module 240 are described herein with reference to FIGS.14-19B.

The generator module 240 or the device/instrument 235 or both arecoupled to the modular control tower 236 connected to multiple operatingtheater devices such as, for example, intelligent surgical instruments,robots, and other computerized devices located in the operating theater,as described with reference to FIGS. 6-9, for example.

FIG. 14 illustrates an example of a generator 900, which is one form ofa generator configured to couple to an ultrasonic instrument and furtherconfigured to execute adaptive ultrasonic blade control algorithms in asurgical data network comprising a modular communication hub as shown inFIG. 13. The generator 900 is configured to deliver multiple energymodalities to a surgical instrument. The generator 900 provides RF andultrasonic signals for delivering energy to a surgical instrument eitherindependently or simultaneously. The RF and ultrasonic signals may beprovided alone or in combination and may be provided simultaneously. Asnoted above, at least one generator output can deliver multiple energymodalities (e.g., ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers) through a single port, and these signals can be deliveredseparately or simultaneously to the end effector to treat tissue. Thegenerator 900 comprises a processor 902 coupled to a waveform generator904. The processor 902 and waveform generator 904 are configured togenerate a variety of signal waveforms based on information stored in amemory coupled to the processor 902, not shown for clarity ofdisclosure. The digital information associated with a waveform isprovided to the waveform generator 904 which includes one or more DACcircuits to convert the digital input into an analog output. The analogoutput is fed to an amplifier 1106 for signal conditioning andamplification. The conditioned and amplified output of the amplifier 906is coupled to a power transformer 908. The signals are coupled acrossthe power transformer 908 to the secondary side, which is in the patientisolation side. A first signal of a first energy modality is provided tothe surgical instrument between the terminals labeled ENERGY1 andRETURN. A second signal of a second energy modality is coupled across acapacitor 910 and is provided to the surgical instrument between theterminals labeled ENERGY2 and RETURN. It will be appreciated that morethan two energy modalities may be output and thus the subscript “n” maybe used to designate that up to n ENERGYn terminals may be provided,where n is a positive integer greater than 1. It also will beappreciated that up to “n” return paths RETURNn may be provided withoutdeparting from the scope of the present disclosure.

A first voltage sensing circuit 912 is coupled across the terminalslabeled ENERGY1 and the RETURN path to measure the output voltagetherebetween. A second voltage sensing circuit 924 is coupled across theterminals labeled ENERGY2 and the RETURN path to measure the outputvoltage therebetween. A current sensing circuit 914 is disposed inseries with the RETURN leg of the secondary side of the powertransformer 908 as shown to measure the output current for either energymodality. If different return paths are provided for each energymodality, then a separate current sensing circuit should be provided ineach return leg. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to respective isolation transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 918. The outputs of the isolationtransformers 916, 928, 922 in the on the primary side of the powertransformer 908 (non-patient isolated side) are provided to a one ormore ADC circuit 926. The digitized output of the ADC circuit 926 isprovided to the processor 902 for further processing and computation.The output voltages and output current feedback information can beemployed to adjust the output voltage and current provided to thesurgical instrument and to compute output impedance, among otherparameters. Input/output communications between the processor 902 andpatient isolated circuits is provided through an interface circuit 920.Sensors also may be in electrical communication with the processor 902by way of the interface circuit 920.

In one aspect, the impedance may be determined by the processor 902 bydividing the output of either the first voltage sensing circuit 912coupled across the terminals labeled ENERGY1/RETURN or the secondvoltage sensing circuit 924 coupled across the terminals labeledENERGY2/RETURN by the output of the current sensing circuit 914 disposedin series with the RETURN leg of the secondary side of the powertransformer 908. The outputs of the first and second voltage sensingcircuits 912, 924 are provided to separate isolations transformers 916,922 and the output of the current sensing circuit 914 is provided toanother isolation transformer 916. The digitized voltage and currentsensing measurements from the ADC circuit 926 are provided the processor902 for computing impedance. As an example, the first energy modalityENERGY1 may be ultrasonic energy and the second energy modality ENERGY2may be RF energy. Nevertheless, in addition to ultrasonic and bipolar ormonopolar RF energy modalities, other energy modalities includeirreversible and/or reversible electroporation and/or microwave energy,among others. Also, although the example illustrated in FIG. 21 shows asingle return path RETURN may be provided for two or more energymodalities, in other aspects, multiple return paths RETURNn may beprovided for each energy modality ENERGYn. Thus, as described herein,the ultrasonic transducer impedance may be measured by dividing theoutput of the first voltage sensing circuit 912 by the current sensingcircuit 914 and the tissue impedance may be measured by dividing theoutput of the second voltage sensing circuit 924 by the current sensingcircuit 914.

As shown in FIG. 14, the generator 900 comprising at least one outputport can include a power transformer 908 with a single output and withmultiple taps to provide power in the form of one or more energymodalities, such as ultrasonic, bipolar or monopolar RF, irreversibleand/or reversible electroporation, and/or microwave energy, amongothers, for example, to the end effector depending on the type oftreatment of tissue being performed. For example, the generator 900 candeliver energy with higher voltage and lower current to drive anultrasonic transducer, with lower voltage and higher current to drive RFelectrodes for sealing tissue, or with a coagulation waveform for spotcoagulation using either monopolar or bipolar RF electrosurgicalelectrodes. The output waveform from the generator 900 can be steered,switched, or filtered to provide the frequency to the end effector ofthe surgical instrument. The connection of an ultrasonic transducer tothe generator 900 output would be preferably located between the outputlabeled ENERGY1 and RETURN as shown in FIG. 14. In one example, aconnection of RF bipolar electrodes to the generator 900 output would bepreferably located between the output labeled ENERGY2 and RETURN. In thecase of monopolar output, the preferred connections would be activeelectrode (e.g., pencil or other surgical probe) to the ENERGY2 outputand a suitable return pad connected to the RETURN output.

Additional details are disclosed in U.S. Patent Application PublicationNo. 2017/0086914, titled TECHNIQUES FOR OPERATING GENERATOR FORDIGITALLY GENERATING ELECTRICAL SIGNAL WAVEFORMS AND SURGICALINSTRUMENTS, which published on Mar. 30, 2017, which is hereinincorporated by reference in its entirety.

As used throughout this description, the term “wireless” and itsderivatives may be used to describe circuits, devices, systems, methods,techniques, communications channels, etc., that may communicate datathrough the use of modulated electromagnetic radiation through anon-solid medium. The term does not imply that the associated devices donot contain any wires, although in some aspects they might not. Thecommunication module may implement any of a number of wireless or wiredcommunication standards or protocols, including but not limited to Wi-Fi(IEEE 802.11 family), WiMAX (IEEE 802.16 family), IEEE 802.20, long termevolution (LTE), Ev-DO, HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA,TDMA, DECT, Bluetooth, Ethernet derivatives thereof, as well as anyother wireless and wired protocols that are designated as 3G, 4G, 5G,and beyond. The computing module may include a plurality ofcommunication modules. For instance, a first communication module may bededicated to shorter range wireless communications such as Wi-Fi andBluetooth and a second communication module may be dedicated to longerrange wireless communications such as GPS, EDGE, GPRS, CDMA, WiMAX, LTE,Ev-DO, and others.

As used herein a processor or processing unit is an electronic circuitwhich performs operations on some external data source, usually memoryor some other data stream. The term is used herein to refer to thecentral processor (central processing unit) in a system or computersystems (especially systems on a chip (SoCs)) that combine a number ofspecialized “processors.”

As used herein, a system on a chip or system on chip (SoC or SOC) is anintegrated circuit (also known as an “IC” or “chip”) that integrates allcomponents of a computer or other electronic systems. It may containdigital, analog, mixed-signal, and often radio-frequency functions—allon a single substrate. A SoC integrates a microcontroller (ormicroprocessor) with advanced peripherals like graphics processing unit(GPU), Wi-Fi module, or coprocessor. A SoC may or may not containbuilt-in memory.

As used herein, a microcontroller or controller is a system thatintegrates a microprocessor with peripheral circuits and memory. Amicrocontroller (or MCU for microcontroller unit) may be implemented asa small computer on a single integrated circuit. It may be similar to aSoC; an SoC may include a microcontroller as one of its components. Amicrocontroller may contain one or more core processing units (CPUs)along with memory and programmable input/output peripherals. Programmemory in the form of Ferroelectric RAM, NOR flash or OTP ROM is alsooften included on chip, as well as a small amount of RAM.Microcontrollers may be employed for embedded applications, in contrastto the microprocessors used in personal computers or other generalpurpose applications consisting of various discrete chips.

As used herein, the term controller or microcontroller may be astand-alone IC or chip device that interfaces with a peripheral device.This may be a link between two parts of a computer or a controller on anexternal device that manages the operation of (and connection with) thatdevice.

Any of the processors or microcontrollers described herein, may beimplemented by any single core or multicore processor such as thoseknown under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising on-chipmemory of 256 KB single-cycle flash memory, or other non-volatilememory, up to 40 MHz, a prefetch buffer to improve performance above 40MHz, a 32 KB single-cycle serial random access memory (SRAM), internalread-only memory (ROM) loaded with StellarisWare® software, 2 KBelectrically erasable programmable read-only memory (EEPROM), one ormore pulse width modulation (PWM) modules, one or more quadratureencoder inputs (QEI) analog, one or more 12-bit Analog-to-DigitalConverters (ADC) with 12 analog input channels, details of which areavailable for the product datasheet.

In one aspect, the processor may comprise a safety controller comprisingtwo controller-based families such as TMS570 and RM4× known under thetrade name Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

Modular devices include the modules (as described in connection withFIGS. 3 and 9, for example) that are receivable within a surgical huband the surgical devices or instruments that can be connected to thevarious modules in order to connect or pair with the correspondingsurgical hub. The modular devices include, for example, intelligentsurgical instruments, medical imaging devices, suction/irrigationdevices, smoke evacuators, energy generators, ventilators, insufflators,and displays. The modular devices described herein can be controlled bycontrol algorithms. The control algorithms can be executed on themodular device itself, on the surgical hub to which the particularmodular device is paired, or on both the modular device and the surgicalhub (e.g., via a distributed computing architecture). In someexemplifications, the modular devices' control algorithms control thedevices based on data sensed by the modular device itself (i.e., bysensors in, on, or connected to the modular device). This data can berelated to the patient being operated on (e.g., tissue properties orinsufflation pressure) or the modular device itself (e.g., the rate atwhich a knife is being advanced, motor current, or energy levels). Forexample, a control algorithm for a surgical stapling and cuttinginstrument can control the rate at which the instrument's motor drivesits knife through tissue according to resistance encountered by theknife as it advances.

FIG. 15 illustrates one form of a surgical system 1000 comprising agenerator 1100 and various surgical instruments 1104, 1106, 1108 usabletherewith, where the surgical instrument 1104 is an ultrasonic surgicalinstrument, the surgical instrument 1106 is an RF electrosurgicalinstrument, and the multifunction surgical instrument 1108 is acombination ultrasonic/RF electrosurgical instrument. The generator 1100is configurable for use with a variety of surgical instruments.According to various forms, the generator 1100 may be configurable foruse with different surgical instruments of different types including,for example, ultrasonic surgical instruments 1104, RF electrosurgicalinstruments 1106, and multifunction surgical instruments 1108 thatintegrate RF and ultrasonic energies delivered simultaneously from thegenerator 1100. Although in the form of FIG. 15 the generator 1100 isshown separate from the surgical instruments 1104, 1106, 1108 in oneform, the generator 1100 may be formed integrally with any of thesurgical instruments 1104, 1106, 1108 to form a unitary surgical system.The generator 1100 comprises an input device 1110 located on a frontpanel of the generator 1100 console. The input device 1110 may compriseany suitable device that generates signals suitable for programming theoperation of the generator 1100. The generator 1100 may be configuredfor wired or wireless communication

The generator 1100 is configured to drive multiple surgical instruments1104, 1106, 1108. The first surgical instrument is an ultrasonicsurgical instrument 1104 and comprises a handpiece 1105 (HP), anultrasonic transducer 1120, a shaft 1126, and an end effector 1122. Theend effector 1122 comprises an ultrasonic blade 1128 acousticallycoupled to the ultrasonic transducer 1120 and a clamp arm 1140. Thehandpiece 1105 comprises a trigger 1143 to operate the clamp arm 1140and a combination of the toggle buttons 1134 a, 1134 b, 1134 c toenergize and drive the ultrasonic blade 1128 or other function. Thetoggle buttons 1134 a, 1134 b, 1134 c can be configured to energize theultrasonic transducer 1120 with the generator 1100.

The generator 1100 also is configured to drive a second surgicalinstrument 1106. The second surgical instrument 1106 is an RFelectrosurgical instrument and comprises a handpiece 1107 (HP), a shaft1127, and an end effector 1124. The end effector 1124 compriseselectrodes in clamp arms 1142 a, 1142 b and return through an electricalconductor portion of the shaft 1127. The electrodes are coupled to andenergized by a bipolar energy source within the generator 1100. Thehandpiece 1107 comprises a trigger 1145 to operate the clamp arms 1142a, 1142 b and an energy button 1135 to actuate an energy switch toenergize the electrodes in the end effector 1124.

The generator 1100 also is configured to drive a multifunction surgicalinstrument 1108. The multifunction surgical instrument 1108 comprises ahandpiece 1109 (HP), a shaft 1129, and an end effector 1125. The endeffector 1125 comprises an ultrasonic blade 1149 and a clamp arm 1146.The ultrasonic blade 1149 is acoustically coupled to the ultrasonictransducer 1120. The handpiece 1109 comprises a trigger 1147 to operatethe clamp arm 1146 and a combination of the toggle buttons 1137 a, 1137b, 1137 c to energize and drive the ultrasonic blade 1149 or otherfunction. The toggle buttons 1137 a, 1137 b, 1137 c can be configured toenergize the ultrasonic transducer 1120 with the generator 1100 andenergize the ultrasonic blade 1149 with a bipolar energy source alsocontained within the generator 1100. It will be appreciated that thehandpiece 1105, 1107, 1109 may be replaced with a robotically controlledinstrument. Accordingly, the term handpiece should not be limited inthis context.

The generator 1100 is configurable for use with a variety of surgicalinstruments. According to various forms, the generator 1100 may beconfigurable for use with different surgical instruments of differenttypes including, for example, the ultrasonic surgical instrument 1104,the RF electrosurgical instrument 1106, and the multifunction surgicalinstrument 1108 that integrates RF and ultrasonic energies deliveredsimultaneously from the generator 1100. Although in the form of FIG. 15the generator 1100 is shown separate from the surgical instruments 1104,1106, 1108, in another form the generator 1100 may be formed integrallywith any one of the surgical instruments 1104, 1106, 1108 to form aunitary surgical system. As discussed above, the generator 1100comprises an input device 1110 located on a front panel of the generator1100 console. The input device 1110 may comprise any suitable devicethat generates signals suitable for programming the operation of thegenerator 1100. The generator 1100 also may comprise one or more outputdevices 1112. Further aspects of generators for digitally generatingelectrical signal waveforms and surgical instruments are described in USpatent publication US-2017-0086914-A1, which is herein incorporated byreference in its entirety.

In various aspects, the generator 1100 may comprise several separatefunctional elements, such as modules and/or blocks, as shown in FIG. 16,a diagram of the surgical system 1000 of FIG. 15. Different functionalelements or modules may be configured for driving the different kinds ofsurgical devices 1104, 1106, 1108. For example an ultrasonic generatormodule may drive an ultrasonic device, such as the ultrasonic device1104. An electrosurgery/RF generator module may drive theelectrosurgical device 1106. The modules may generate respective drivesignals for driving the surgical devices 1104, 1106, 1108. In variousaspects, the ultrasonic generator module and/or the electrosurgery/RFgenerator module each may be formed integrally with the generator 1100.Alternatively, one or more of the modules may be provided as a separatecircuit module electrically coupled to the generator 1100. (The modulesare shown in phantom to illustrate this option.) Also, in some aspects,the electrosurgery/RF generator module may be formed integrally with theultrasonic generator module, or vice versa.

In accordance with the described aspects, the ultrasonic generatormodule may produce a drive signal or signals of particular voltages,currents, and frequencies (e.g. 55,500 cycles per second, or Hz). Thedrive signal or signals may be provided to the ultrasonic device 1104,and specifically to the transducer 1120, which may operate, for example,as described above. In one aspect, the generator 1100 may be configuredto produce a drive signal of a particular voltage, current, and/orfrequency output signal that can be stepped with high resolution,accuracy, and repeatability.

In accordance with the described aspects, the electrosurgery/RFgenerator module may generate a drive signal or signals with outputpower sufficient to perform bipolar electrosurgery using radio frequency(RF) energy. In bipolar electrosurgery applications, the drive signalmay be provided, for example, to the electrodes of the electrosurgicaldevice 1106, for example, as described above. Accordingly, the generator1100 may be configured for therapeutic purposes by applying electricalenergy to the tissue sufficient for treating the tissue (e.g.,coagulation, cauterization, tissue welding, etc.).

The generator 1100 may comprise an input device 2150 (FIG. 18B) located,for example, on a front panel of the generator 1100 console. The inputdevice 2150 may comprise any suitable device that generates signalssuitable for programming the operation of the generator 1100. Inoperation, the user can program or otherwise control operation of thegenerator 1100 using the input device 2150. The input device 2150 maycomprise any suitable device that generates signals that can be used bythe generator (e.g., by one or more processors contained in thegenerator) to control the operation of the generator 1100 (e.g.,operation of the ultrasonic generator module and/or electrosurgery/RFgenerator module). In various aspects, the input device 2150 includesone or more of: buttons, switches, thumbwheels, keyboard, keypad, touchscreen monitor, pointing device, remote connection to a general purposeor dedicated computer. In other aspects, the input device 2150 maycomprise a suitable user interface, such as one or more user interfacescreens displayed on a touch screen monitor, for example. Accordingly,by way of the input device 2150, the user can set or program variousoperating parameters of the generator, such as, for example, current(I), voltage (V), frequency (f), and/or period (T) of a drive signal orsignals generated by the ultrasonic generator module and/orelectrosurgery/RF generator module.

The generator 1100 may also comprise an output device 2140 (FIG. 18B)located, for example, on a front panel of the generator 1100 console.The output device 2140 includes one or more devices for providing asensory feedback to a user. Such devices may comprise, for example,visual feedback devices (e.g., an LCD display screen, LED indicators),audio feedback devices (e.g., a speaker, a buzzer) or tactile feedbackdevices (e.g., haptic actuators).

Although certain modules and/or blocks of the generator 1100 may bedescribed by way of example, it can be appreciated that a greater orlesser number of modules and/or blocks may be used and still fall withinthe scope of the aspects. Further, although various aspects may bedescribed in terms of modules and/or blocks to facilitate description,such modules and/or blocks may be implemented by one or more hardwarecomponents, e.g., processors, Digital Signal Processors (DSPs),Programmable Logic Devices (PLDs), Application Specific IntegratedCircuits (ASICs), circuits, registers and/or software components, e.g.,programs, subroutines, logic and/or combinations of hardware andsoftware components.

In one aspect, the ultrasonic generator drive module andelectrosurgery/RF drive module 1110 (FIG. 15) may comprise one or moreembedded applications implemented as firmware, software, hardware, orany combination thereof. The modules may comprise various executablemodules such as software, programs, data, drivers, application programinterfaces (APIs), and so forth. The firmware may be stored innonvolatile memory (NVM), such as in bit-masked read-only memory (ROM)or flash memory. In various implementations, storing the firmware in ROMmay preserve flash memory. The NVM may comprise other types of memoryincluding, for example, programmable ROM (PROM), erasable programmableROM (EPROM), electrically erasable programmable ROM (EEPROM), or batterybacked random-access memory (RAM) such as dynamic RAM (DRAM),Double-Data-Rate DRAM (DDRAM), and/or synchronous DRAM (SDRAM).

In one aspect, the modules comprise a hardware component implemented asa processor for executing program instructions for monitoring variousmeasurable characteristics of the devices 1104, 1106, 1108 andgenerating a corresponding output drive signal or signals for operatingthe devices 1104, 1106, 1108. In aspects in which the generator 1100 isused in conjunction with the device 1104, the drive signal may drive theultrasonic transducer 1120 in cutting and/or coagulation operatingmodes. Electrical characteristics of the device 1104 and/or tissue maybe measured and used to control operational aspects of the generator1100 and/or provided as feedback to the user. In aspects in which thegenerator 1100 is used in conjunction with the device 1106, the drivesignal may supply electrical energy (e.g., RF energy) to the endeffector 1124 in cutting, coagulation and/or desiccation modes.Electrical characteristics of the device 1106 and/or tissue may bemeasured and used to control operational aspects of the generator 1100and/or provided as feedback to the user. In various aspects, aspreviously discussed, the hardware components may be implemented as DSP,PLD, ASIC, circuits, and/or registers. In one aspect, the processor maybe configured to store and execute computer software programinstructions to generate the step function output signals for drivingvarious components of the devices 1104, 1106, 1108, such as theultrasonic transducer 1120 and the end effectors 1122, 1124, 1125.

FIG. 17 is a simplified block diagram of one aspect of the generator1100 for providing inductorless tuning as described above, among otherbenefits. FIGS. 18A-18C illustrate an architecture of the generator 1100of FIG. 17 according to one aspect. With reference to FIG. 17, thegenerator 1100 may comprise a patient isolated stage 1520 incommunication with a non-isolated stage 1540 via a power transformer1560. A secondary winding 1580 of the power transformer 1560 iscontained in the isolated stage 1520 and may comprise a tappedconfiguration (e.g., a center-tapped or non-center tapped configuration)to define drive signal outputs 1600 a, 1600 b, 1600 c for outputtingdrive signals to different surgical devices, such as, for example, anultrasonic surgical device 1104 and an electrosurgical device 1106. Inparticular, drive signal outputs 1600 a, 1600 b, 1600 c may output adrive signal (e.g., a 420V RMS drive signal) to an ultrasonic surgicaldevice 1104, and drive signal outputs 1600 a, 1600 b, 1600 c may outputa drive signal (e.g., a 100V RMS drive signal) to an electrosurgicaldevice 1106, with output 1600 b corresponding to the center tap of thepower transformer 1560. The non-isolated stage 1540 may comprise a poweramplifier 1620 having an output connected to a primary winding 1640 ofthe power transformer 1560. In certain aspects the power amplifier 1620may comprise a push-pull amplifier, for example. The non-isolated stage1540 may further comprise a programmable logic device 1660 for supplyinga digital output to a digital-to-analog converter (DAC) 1680, which inturn supplies a corresponding analog signal to an input of the poweramplifier 1620. In certain aspects the programmable logic device 1660may comprise a field-programmable gate array (FPGA), for example. Theprogrammable logic device 1660, by virtue of controlling the poweramplifier's 1620 input via the DAC 1680, may therefore control any of anumber of parameters (e.g., frequency, waveform shape, waveformamplitude) of drive signals appearing at the drive signal outputs 1600a, 1600 b, 1600 c. In certain aspects and as discussed below, theprogrammable logic device 1660, in conjunction with a processor (e.g.,processor 1740 discussed below), may implement a number of digitalsignal processing (DSP)-based and/or other control algorithms to controlparameters of the drive signals output by the generator 1100.

Power may be supplied to a power rail of the power amplifier 1620 by aswitch-mode regulator 1700. In certain aspects the switch-mode regulator1700 may comprise an adjustable buck regulator, for example. Asdiscussed above, the non-isolated stage 1540 may further comprise aprocessor 1740, which in one aspect may comprise a DSP processor such asan ADSP-21469 SHARC DSP, available from Analog Devices, Norwood, Mass.,for example. In certain aspects the processor 1740 may control operationof the switch-mode power converter 1700 responsive to voltage feedbackdata received from the power amplifier 1620 by the processor 1740 via ananalog-to-digital converter (ADC) 1760. In one aspect, for example, theprocessor 1740 may receive as input, via the ADC 1760, the waveformenvelope of a signal (e.g., an RF signal) being amplified by the poweramplifier 1620. The processor 1740 may then control the switch-moderegulator 1700 (e.g., via a pulse-width modulated (PWM) output) suchthat the rail voltage supplied to the power amplifier 1620 tracks thewaveform envelope of the amplified signal. By dynamically modulating therail voltage of the power amplifier 1620 based on the waveform envelope,the efficiency of the power amplifier 1620 may be significantly improvedrelative to a fixed rail voltage amplifier scheme. The processor 1740may be configured for wired or wireless communication.

In certain aspects and as discussed in further detail in connection withFIGS. 19A-19B, the programmable logic device 1660, in conjunction withthe processor 1740, may implement a direct digital synthesizer (DDS)control scheme to control the waveform shape, frequency and/or amplitudeof drive signals output by the generator 1100. In one aspect, forexample, the programmable logic device 1660 may implement a DDS controlalgorithm 2680 (FIG. 14A) by recalling waveform samples stored in adynamically-updated look-up table (LUT), such as a RAM LUT which may beembedded in an FPGA. This control algorithm is particularly useful forultrasonic applications in which an ultrasonic transducer, such as theultrasonic transducer 1120, may be driven by a clean sinusoidal currentat its resonant frequency. Because other frequencies may exciteparasitic resonances, minimizing or reducing the total distortion of themotional branch current may correspondingly minimize or reduceundesirable resonance effects. Because the waveform shape of a drivesignal output by the generator 1100 is impacted by various sources ofdistortion present in the output drive circuit (e.g., the powertransformer 1560, the power amplifier 1620), voltage and currentfeedback data based on the drive signal may be input into an algorithm,such as an error control algorithm implemented by the processor 1740,which compensates for distortion by suitably pre-distorting or modifyingthe waveform samples stored in the LUT on a dynamic, ongoing basis(e.g., in real-time). In one aspect, the amount or degree ofpre-distortion applied to the LUT samples may be based on the errorbetween a computed motional branch current and a desired currentwaveform shape, with the error being determined on a sample-by samplebasis. In this way, the pre-distorted LUT samples, when processedthrough the drive circuit, may result in a motional branch drive signalhaving the desired waveform shape (e.g., sinusoidal) for optimallydriving the ultrasonic transducer. In such aspects, the LUT waveformsamples will therefore not represent the desired waveform shape of thedrive signal, but rather the waveform shape that is required toultimately produce the desired waveform shape of the motional branchdrive signal when distortion effects are taken into account.

The non-isolated stage 1540 may further comprise an ADC 1780 and an ADC1800 coupled to the output of the power transformer 1560 via respectiveisolation transformers 1820, 1840 for respectively sampling the voltageand current of drive signals output by the generator 1100. In certainaspects, the ADCs 1780, 1800 may be configured to sample at high speeds(e.g., 80 Msps) to enable oversampling of the drive signals. In oneaspect, for example, the sampling speed of the ADCs 1780, 1800 mayenable approximately 200× (depending on drive frequency) oversampling ofthe drive signals. In certain aspects, the sampling operations of theADCs 1780, 1800 may be performed by a single ADC receiving input voltageand current signals via a two-way multiplexer. The use of high-speedsampling in aspects of the generator 1100 may enable, among otherthings, calculation of the complex current flowing through the motionalbranch (which may be used in certain aspects to implement DDS-basedwaveform shape control described above), accurate digital filtering ofthe sampled signals, and calculation of real power consumption with ahigh degree of precision. Voltage and current feedback data output bythe ADCs 1780, 1800 may be received and processed (e.g., FIFO buffering,multiplexing) by the programmable logic device 1660 and stored in datamemory for subsequent retrieval by, for example, the processor 1740. Asnoted above, voltage and current feedback data may be used as input toan algorithm for pre-distorting or modifying LUT waveform samples on adynamic and ongoing basis. In certain aspects, this may require eachstored voltage and current feedback data pair to be indexed based on, orotherwise associated with, a corresponding LUT sample that was output bythe programmable logic device 1660 when the voltage and current feedbackdata pair was acquired. Synchronization of the LUT samples and thevoltage and current feedback data in this manner contributes to thecorrect timing and stability of the pre-distortion algorithm.

In certain aspects, the voltage and current feedback data may be used tocontrol the frequency and/or amplitude (e.g., current amplitude) of thedrive signals. In one aspect, for example, voltage and current feedbackdata may be used to determine impedance phase, e.g., the phasedifference between the voltage and current drive signals. The frequencyof the drive signal may then be controlled to minimize or reduce thedifference between the determined impedance phase and an impedance phasesetpoint (e.g., 0°), thereby minimizing or reducing the effects ofharmonic distortion and correspondingly enhancing impedance phasemeasurement accuracy. The determination of phase impedance and afrequency control signal may be implemented in the processor 1740, forexample, with the frequency control signal being supplied as input to aDDS control algorithm implemented by the programmable logic device 1660.

The impedance phase may be determined through Fourier analysis. In oneaspect, the phase difference between the generator voltage V_(g)(t) andgenerator current I_(g)(t) driving signals may be determined using theFast Fourier Transform (FFT) or the Discrete Fourier Transform (DFT) asfollows:

V_(g)(t) = A₁cos (2π f₀t + φ₁) I_(g)(t) = A₂cos (2π f₀t + φ₂)${V_{g}(f)} = {\frac{A_{1}}{2}\left( {{\delta\left( {f - f_{0}} \right)} + {\delta\left( {f + f_{0}} \right)}} \right){\exp\left( {j\; 2\pi\; f\frac{\varphi_{1}}{2\pi\; f_{0}}} \right)}}$${I_{g}(f)} = {\frac{A_{2}}{2}\left( {{\delta\left( {f - f_{0}} \right)} + {\delta\left( {f + f_{0}} \right)}} \right){\exp\left( {j\; 2\pi\; f\frac{\varphi_{2}}{2\pi\; f_{0}}} \right)}}$

Evaluating the Fourier Transform at the frequency of the sinusoidyields:

${V_{g}\left( f_{0} \right)} = {{\frac{A_{1}}{2}{\delta(0)}{\exp\left( {j\;\varphi_{1}} \right)}\mspace{14mu}\arg\;{V\left( f_{0} \right)}} = \varphi_{1}}$${I_{g}\left( f_{0} \right)} = {{\frac{A_{2}}{2}{\delta(0)}{\exp\left( {j\;\varphi_{2}} \right)}\mspace{14mu}{{\arg I}\left( f_{0} \right)}} = \varphi_{2}}$

Other approaches include weighted least-squares estimation, Kalmanfiltering, and space-vector-based techniques. Virtually all of theprocessing in an FFT or DFT technique may be performed in the digitaldomain with the aid of the 2-channel high speed ADC 1780, 1800, forexample. In one technique, the digital signal samples of the voltage andcurrent signals are Fourier transformed with an FFT or a DFT. The phaseangle φ at any point in time can be calculated by:φ=2πft+φ ₀

where φ is the phase angle, f is the frequency, t is time, and φ₀ is thephase at t=0.

Another technique for determining the phase difference between thevoltage V_(g)(t) and current I_(g)(t) signals is the zero-crossingmethod and produces highly accurate results. For voltage V_(g)(t) andcurrent I_(g)(t) signals having the same frequency, each negative topositive zero-crossing of voltage signal V_(g)(t) triggers the start ofa pulse, while each negative to positive zero-crossing of current signalI_(g)(t) triggers the end of the pulse. The result is a pulse train witha pulse width proportional to the phase angle between the voltage signaland the current signal. In one aspect, the pulse train may be passedthrough an averaging filter to yield a measure of the phase difference.Furthermore, if the positive to negative zero crossings also are used ina similar manner, and the results averaged, any effects of DC andharmonic components can be reduced. In one implementation, the analogvoltage V_(g)(t) and current I_(g)(t) signals are converted to digitalsignals that are high if the analog signal is positive and low if theanalog signal is negative. High accuracy phase estimates require sharptransitions between high and low. In one aspect, a Schmitt trigger alongwith an RC stabilization network may be employed to convert the analogsignals into digital signals. In other aspects, an edge triggered RSflip-flop and ancillary circuitry may be employed. In yet anotheraspect, the zero-crossing technique may employ an eXclusive OR (XOR)gate.

Other techniques for determining the phase difference between thevoltage and current signals include Lissajous figures and monitoring theimage; methods such as the three-voltmeter method, the crossed-coilmethod, vector voltmeter and vector impedance methods; and using phasestandard instruments, phase-locked loops, and other techniques asdescribed in Phase Measurement, Peter O'Shea, 2000 CRC Press LLC,<http://www.engnetbase.com>, which is incorporated herein by reference.

In another aspect, for example, the current feedback data may bemonitored in order to maintain the current amplitude of the drive signalat a current amplitude setpoint. The current amplitude setpoint may bespecified directly or determined indirectly based on specified voltageamplitude and power setpoints. In certain aspects, control of thecurrent amplitude may be implemented by control algorithm, such as, forexample, a proportional-integral-derivative (PID) control algorithm, inthe processor 1740. Variables controlled by the control algorithm tosuitably control the current amplitude of the drive signal may include,for example, the scaling of the LUT waveform samples stored in theprogrammable logic device 1660 and/or the full-scale output voltage ofthe DAC 1680 (which supplies the input to the power amplifier 1620) viaa DAC 1860.

The non-isolated stage 1540 may further comprise a processor 1900 forproviding, among other things, user interface (UI) functionality. In oneaspect, the processor 1900 may comprise an Atmel AT91 SAM9263 processorhaving an ARM 926EJ-S core, available from Atmel Corporation, San Jose,Calif., for example. Examples of UI functionality supported by theprocessor 1900 may include audible and visual user feedback,communication with peripheral devices (e.g., via a Universal Serial Bus(USB) interface), communication with a foot switch 1430, communicationwith an input device 2150 (e.g., a touch screen display) andcommunication with an output device 2140 (e.g., a speaker). Theprocessor 1900 may communicate with the processor 1740 and theprogrammable logic device (e.g., via a serial peripheral interface (SPI)bus). Although the processor 1900 may primarily support UIfunctionality, it may also coordinate with the processor 1740 toimplement hazard mitigation in certain aspects. For example, theprocessor 1900 may be programmed to monitor various aspects of userinput and/or other inputs (e.g., touch screen inputs 2150, foot switch1430 inputs, temperature sensor inputs 2160) and may disable the driveoutput of the generator 1100 when an erroneous condition is detected.

In certain aspects, both the processor 1740 (FIG. 17, 18A) and theprocessor 1900 (FIG. 17, 18B) may determine and monitor the operatingstate of the generator 1100. For processor 1740, the operating state ofthe generator 1100 may dictate, for example, which control and/ordiagnostic processes are implemented by the processor 1740. Forprocessor 1900, the operating state of the generator 1100 may dictate,for example, which elements of a user interface (e.g., display screens,sounds) are presented to a user. The processors 1740, 1900 mayindependently maintain the current operating state of the generator 1100and recognize and evaluate possible transitions out of the currentoperating state. The processor 1740 may function as the master in thisrelationship and determine when transitions between operating states areto occur. The processor 1900 may be aware of valid transitions betweenoperating states and may confirm if a particular transition isappropriate. For example, when the processor 1740 instructs theprocessor 1900 to transition to a specific state, the processor 1900 mayverify that the requested transition is valid. In the event that arequested transition between states is determined to be invalid by theprocessor 1900, the processor 1900 may cause the generator 1100 to entera failure mode.

The non-isolated stage 1540 may further comprise a controller 1960 (FIG.17, 18B) for monitoring input devices 2150 (e.g., a capacitive touchsensor used for turning the generator 1100 on and off, a capacitivetouch screen). In certain aspects, the controller 1960 may comprise atleast one processor and/or other controller device in communication withthe processor 1900. In one aspect, for example, the controller 1960 maycomprise a processor (e.g., a Mega168 8-bit controller available fromAtmel) configured to monitor user input provided via one or morecapacitive touch sensors. In one aspect, the controller 1960 maycomprise a touch screen controller (e.g., a QT5480 touch screencontroller available from Atmel) to control and manage the acquisitionof touch data from a capacitive touch screen.

In certain aspects, when the generator 1100 is in a “power off” state,the controller 1960 may continue to receive operating power (e.g., via aline from a power supply of the generator 1100, such as the power supply2110 (FIG. 17) discussed below). In this way, the controller 1960 maycontinue to monitor an input device 2150 (e.g., a capacitive touchsensor located on a front panel of the generator 1100) for turning thegenerator 1100 on and off. When the generator 1100 is in the “power off”state, the controller 1960 may wake the power supply (e.g., enableoperation of one or more DC/DC voltage converters 2130 (FIG. 17) of thepower supply 2110) if activation of the “on/off” input device 2150 by auser is detected. The controller 1960 may therefore initiate a sequencefor transitioning the generator 1100 to a “power on” state. Conversely,the controller 1960 may initiate a sequence for transitioning thegenerator 1100 to the “power off” state if activation of the “on/off”input device 2150 is detected when the generator 1100 is in the “poweron” state. In certain aspects, for example, the controller 1960 mayreport activation of the “on/off” input device 2150 to the processor1900, which in turn implements the necessary process sequence fortransitioning the generator 1100 to the “power off” state. In suchaspects, the controller 1960 may have no independent ability for causingthe removal of power from the generator 1100 after its “power on” statehas been established.

In certain aspects, the controller 1960 may cause the generator 1100 toprovide audible or other sensory feedback for alerting the user that a“power on” or “power off” sequence has been initiated. Such an alert maybe provided at the beginning of a “power on” or “power off” sequence andprior to the commencement of other processes associated with thesequence.

In certain aspects, the isolated stage 1520 may comprise an instrumentinterface circuit 1980 to, for example, provide a communicationinterface between a control circuit of a surgical device (e.g., acontrol circuit comprising handpiece switches) and components of thenon-isolated stage 1540, such as, for example, the programmable logicdevice 1660, the processor 1740 and/or the processor 1900. Theinstrument interface circuit 1980 may exchange information withcomponents of the non-isolated stage 1540 via a communication link thatmaintains a suitable degree of electrical isolation between the stages1520, 1540, such as, for example, an infrared (IR)-based communicationlink. Power may be supplied to the instrument interface circuit 1980using, for example, a low-dropout voltage regulator powered by anisolation transformer driven from the non-isolated stage 1540.

In one aspect, the instrument interface circuit 1980 may comprise aprogrammable logic device 2000 (e.g., an FPGA) in communication with asignal conditioning circuit 2020 (FIG. 17 and FIG. 18C). The signalconditioning circuit 2020 may be configured to receive a periodic signalfrom the programmable logic device 2000 (e.g., a 2 kHz square wave) togenerate a bipolar interrogation signal having an identical frequency.The interrogation signal may be generated, for example, using a bipolarcurrent source fed by a differential amplifier. The interrogation signalmay be communicated to a surgical device control circuit (e.g., by usinga conductive pair in a cable that connects the generator 1100 to thesurgical device) and monitored to determine a state or configuration ofthe control circuit. For example, the control circuit may comprise anumber of switches, resistors and/or diodes to modify one or morecharacteristics (e.g., amplitude, rectification) of the interrogationsignal such that a state or configuration of the control circuit isuniquely discernible based on the one or more characteristics. In oneaspect, for example, the signal conditioning circuit 2020 may comprisean ADC for generating samples of a voltage signal appearing acrossinputs of the control circuit resulting from passage of interrogationsignal therethrough. The programmable logic device 2000 (or a componentof the non-isolated stage 1540) may then determine the state orconfiguration of the control circuit based on the ADC samples.

In one aspect, the instrument interface circuit 1980 may comprise afirst data circuit interface 2040 to enable information exchange betweenthe programmable logic device 2000 (or other element of the instrumentinterface circuit 1980) and a first data circuit disposed in orotherwise associated with a surgical device. In certain aspects, forexample, a first data circuit 2060 may be disposed in a cable integrallyattached to a surgical device handpiece, or in an adaptor forinterfacing a specific surgical device type or model with the generator1100. In certain aspects, the first data circuit may comprise anon-volatile storage device, such as an electrically erasableprogrammable read-only memory (EEPROM) device. In certain aspects andreferring again to FIG. 17, the first data circuit interface 2040 may beimplemented separately from the programmable logic device 2000 andcomprise suitable circuitry (e.g., discrete logic devices, a processor)to enable communication between the programmable logic device 2000 andthe first data circuit. In other aspects, the first data circuitinterface 2040 may be integral with the programmable logic device 2000.

In certain aspects, the first data circuit 2060 may store informationpertaining to the particular surgical device with which it isassociated. Such information may include, for example, a model number, aserial number, a number of operations in which the surgical device hasbeen used, and/or any other type of information. This information may beread by the instrument interface circuit 1980 (e.g., by the programmablelogic device 2000), transferred to a component of the non-isolated stage1540 (e.g., to programmable logic device 1660, processor 1740 and/orprocessor 1900) for presentation to a user via an output device 2140and/or for controlling a function or operation of the generator 1100.Additionally, any type of information may be communicated to first datacircuit 2060 for storage therein via the first data circuit interface2040 (e.g., using the programmable logic device 2000). Such informationmay comprise, for example, an updated number of operations in which thesurgical device has been used and/or dates and/or times of its usage.

As discussed previously, a surgical instrument may be detachable from ahandpiece (e.g., instrument 1106 may be detachable from handpiece 1107)to promote instrument interchangeability and/or disposability. In suchcases, known generators may be limited in their ability to recognizeparticular instrument configurations being used and to optimize controland diagnostic processes accordingly. The addition of readable datacircuits to surgical device instruments to address this issue isproblematic from a compatibility standpoint, however. For example, itmay be impractical to design a surgical device to maintain backwardcompatibility with generators that lack the requisite data readingfunctionality due to, for example, differing signal schemes, designcomplexity and cost. Other aspects of instruments address these concernsby using data circuits that may be implemented in existing surgicalinstruments economically and with minimal design changes to preservecompatibility of the surgical devices with current generator platforms.

Additionally, aspects of the generator 1100 may enable communicationwith instrument-based data circuits. For example, the generator 1100 maybe configured to communicate with a second data circuit (e.g., a datacircuit) contained in an instrument (e.g., instrument 1104, 1106 or1108) of a surgical device. The instrument interface circuit 1980 maycomprise a second data circuit interface 2100 to enable thiscommunication. In one aspect, the second data circuit interface 2100 maycomprise a tri-state digital interface, although other interfaces mayalso be used. In certain aspects, the second data circuit may generallybe any circuit for transmitting and/or receiving data. In one aspect,for example, the second data circuit may store information pertaining tothe particular surgical instrument with which it is associated. Suchinformation may include, for example, a model number, a serial number, anumber of operations in which the surgical instrument has been used,and/or any other type of information. Additionally or alternatively, anytype of information may be communicated to the second data circuit forstorage therein via the second data circuit interface 2100 (e.g., usingthe programmable logic device 2000). Such information may comprise, forexample, an updated number of operations in which the instrument hasbeen used and/or dates and/or times of its usage. In certain aspects,the second data circuit may transmit data acquired by one or moresensors (e.g., an instrument-based temperature sensor). In certainaspects, the second data circuit may receive data from the generator1100 and provide an indication to a user (e.g., an LED indication orother visible indication) based on the received data.

In certain aspects, the second data circuit and the second data circuitinterface 2100 may be configured such that communication between theprogrammable logic device 2000 and the second data circuit can beeffected without the need to provide additional conductors for thispurpose (e.g., dedicated conductors of a cable connecting a handpiece tothe generator 1100). In one aspect, for example, information may becommunicated to and from the second data circuit using a one-wire buscommunication scheme implemented on existing cabling, such as one of theconductors used transmit interrogation signals from the signalconditioning circuit 2020 to a control circuit in a handpiece. In thisway, design changes or modifications to the surgical device that mightotherwise be necessary are minimized or reduced. Moreover, becausedifferent types of communications can be implemented over a commonphysical channel (either with or without frequency-band separation), thepresence of a second data circuit may be “invisible” to generators thatdo not have the requisite data reading functionality, thus enablingbackward compatibility of the surgical device instrument.

In certain aspects, the isolated stage 1520 may comprise at least oneblocking capacitor 2960-1 (FIG. 18C) connected to the drive signaloutput 1600 b to prevent passage of DC current to a patient. A singleblocking capacitor may be required to comply with medical regulations orstandards, for example. While failure in single-capacitor designs isrelatively uncommon, such failure may nonetheless have negativeconsequences. In one aspect, a second blocking capacitor 2960-2 may beprovided in series with the blocking capacitor 2960-1, with currentleakage from a point between the blocking capacitors 2960-1, 2960-2being monitored by, for example, an ADC 2980 for sampling a voltageinduced by leakage current. The samples may be received by theprogrammable logic device 2000, for example. Based on changes in theleakage current (as indicated by the voltage samples in the aspect ofFIG. 17), the generator 1100 may determine when at least one of theblocking capacitors 2960-1, 2960-2 has failed. Accordingly, the aspectof FIG. 17 may provide a benefit over single-capacitor designs having asingle point of failure.

In certain aspects, the non-isolated stage 1540 may comprise a powersupply 2110 for outputting DC power at a suitable voltage and current.The power supply may comprise, for example, a 400 W power supply foroutputting a 48 VDC system voltage. As discussed above, the power supply2110 may further comprise one or more DC/DC voltage converters 2130 forreceiving the output of the power supply to generate DC outputs at thevoltages and currents required by the various components of thegenerator 1100. As discussed above in connection with the controller1960, one or more of the DC/DC voltage converters 2130 may receive aninput from the controller 1960 when activation of the “on/off” inputdevice 2150 by a user is detected by the controller 1960 to enableoperation of, or wake, the DC/DC voltage converters 2130.

FIGS. 19A-19B illustrate certain functional and structural aspects ofone aspect of the generator 1100. Feedback indicating current andvoltage output from the secondary winding 1580 of the power transformer1560 is received by the ADCs 1780, 1800, respectively. As shown, theADCs 1780, 1800 may be implemented as a 2-channel ADC and may sample thefeedback signals at a high speed (e.g., 80 Msps) to enable oversampling(e.g., approximately 200× oversampling) of the drive signals. Thecurrent and voltage feedback signals may be suitably conditioned in theanalog domain (e.g., amplified, filtered) prior to processing by theADCs 1780, 1800. Current and voltage feedback samples from the ADCs1780, 1800 may be individually buffered and subsequently multiplexed orinterleaved into a single data stream within block 2120 of theprogrammable logic device 1660. In the aspect of FIGS. 19A-19B, theprogrammable logic device 1660 comprises an FPGA.

The multiplexed current and voltage feedback samples may be received bya parallel data acquisition port (PDAP) implemented within block 2144 ofthe processor 1740. The PDAP may comprise a packing unit forimplementing any of a number of methodologies for correlating themultiplexed feedback samples with a memory address. In one aspect, forexample, feedback samples corresponding to a particular LUT sampleoutput by the programmable logic device 1660 may be stored at one ormore memory addresses that are correlated or indexed with the LUTaddress of the LUT sample. In another aspect, feedback samplescorresponding to a particular LUT sample output by the programmablelogic device 1660 may be stored, along with the LUT address of the LUTsample, at a common memory location. In any event, the feedback samplesmay be stored such that the address of the LUT sample from which aparticular set of feedback samples originated may be subsequentlyascertained. As discussed above, synchronization of the LUT sampleaddresses and the feedback samples in this way contributes to thecorrect timing and stability of the pre-distortion algorithm. A directmemory access (DMA) controller implemented at block 2166 of theprocessor 1740 may store the feedback samples (and any LUT sampleaddress data, where applicable) at a designated memory location 2180 ofthe processor 1740 (e.g., internal RAM).

Block 2200 of the processor 1740 may implement a pre-distortionalgorithm for pre-distorting or modifying the LUT samples stored in theprogrammable logic device 1660 on a dynamic, ongoing basis. As discussedabove, pre-distortion of the LUT samples may compensate for varioussources of distortion present in the output drive circuit of thegenerator 1100. The pre-distorted LUT samples, when processed throughthe drive circuit, will therefore result in a drive signal having thedesired waveform shape (e.g., sinusoidal) for optimally driving theultrasonic transducer.

At block 2220 of the pre-distortion algorithm, the current through themotional branch of the ultrasonic transducer is determined. The motionalbranch current may be determined using Kirchhoff's Current Law based on,for example, the current and voltage feedback samples stored at memorylocation 2180 (which, when suitably scaled, may be representative of Igand Vg in the model of FIG. 25 discussed above), a value of theultrasonic transducer static capacitance C₀ (measured or known a priori)and a known value of the drive frequency. A motional branch currentsample for each set of stored current and voltage feedback samplesassociated with a LUT sample may be determined.

At block 2240 of the pre-distortion algorithm, each motional branchcurrent sample determined at block 2220 is compared to a sample of adesired current waveform shape to determine a difference, or sampleamplitude error, between the compared samples. For this determination,the sample of the desired current waveform shape may be supplied, forexample, from a waveform shape LUT 2260 containing amplitude samples forone cycle of a desired current waveform shape. The particular sample ofthe desired current waveform shape from the LUT 2260 used for thecomparison may be dictated by the LUT sample address associated with themotional branch current sample used in the comparison. Accordingly, theinput of the motional branch current to block 2240 may be synchronizedwith the input of its associated LUT sample address to block 2240. TheLUT samples stored in the programmable logic device 1660 and the LUTsamples stored in the waveform shape LUT 2260 may therefore be equal innumber. In certain aspects, the desired current waveform shaperepresented by the LUT samples stored in the waveform shape LUT 2260 maybe a fundamental sine wave. Other waveform shapes may be desirable. Forexample, it is contemplated that a fundamental sine wave for drivingmain longitudinal motion of an ultrasonic transducer superimposed withone or more other drive signals at other frequencies, such as a thirdorder harmonic for driving at least two mechanical resonances forbeneficial vibrations of transverse or other modes, could be used.

Each value of the sample amplitude error determined at block 2240 may betransmitted to the LUT of the programmable logic device 1660 (shown atblock 2280 in FIG. 19A) along with an indication of its associated LUTaddress. Based on the value of the sample amplitude error and itsassociated address (and, optionally, values of sample amplitude errorfor the same LUT address previously received), the LUT 2280 (or othercontrol block of the programmable logic device 1660) may pre-distort ormodify the value of the LUT sample stored at the LUT address such thatthe sample amplitude error is reduced or minimized. It will beappreciated that such pre-distortion or modification of each LUT samplein an iterative manner across the entire range of LUT addresses willcause the waveform shape of the generator's output current to match orconform to the desired current waveform shape represented by the samplesof the waveform shape LUT 2260.

Current and voltage amplitude measurements, power measurements andimpedance measurements may be determined at block 2300 of the processor1740 based on the current and voltage feedback samples stored at memorylocation 2180. Prior to the determination of these quantities, thefeedback samples may be suitably scaled and, in certain aspects,processed through a suitable filter 2320 to remove noise resulting from,for example, the data acquisition process and induced harmoniccomponents. The filtered voltage and current samples may thereforesubstantially represent the fundamental frequency of the generator'sdrive output signal. In certain aspects, the filter 2320 may be a finiteimpulse response (FIR) filter applied in the frequency domain. Suchaspects may use the Fast Fourier Transform (FFT) of the output drivesignal current and voltage signals. In certain aspects, the resultingfrequency spectrum may be used to provide additional generatorfunctionality. In one aspect, for example, the ratio of the secondand/or third order harmonic component relative to the fundamentalfrequency component may be used as a diagnostic indicator.

At block 2340 (FIG. 19B), a root mean square (RMS) calculation may beapplied to a sample size of the current feedback samples representing anintegral number of cycles of the drive signal to generate a measurementI_(rms) representing the drive signal output current.

At block 2360, a root mean square (RMS) calculation may be applied to asample size of the voltage feedback samples representing an integralnumber of cycles of the drive signal to determine a measurement V_(rms)representing the drive signal output voltage.

At block 2380, the current and voltage feedback samples may bemultiplied point by point, and a mean calculation is applied to samplesrepresenting an integral number of cycles of the drive signal todetermine a measurement P_(r) of the generator's real output power.

At block 2400, measurement P_(a) of the generator's apparent outputpower may be determined as the product V_(rms)·I_(rms).

At block 2420, measurement Z_(m) of the load impedance magnitude may bedetermined as the quotient V_(rms)/I_(rms).

In certain aspects, the quantities I_(rms), V_(rms), P_(r), P_(a) andZ_(m) determined at blocks 2340, 2360, 2380, 2400 and 2420 may be usedby the generator 1100 to implement any of a number of control and/ordiagnostic processes. In certain aspects, any of these quantities may becommunicated to a user via, for example, an output device 2140 integralwith the generator 1100 or an output device 2140 connected to thegenerator 1100 through a suitable communication interface (e.g., a USBinterface). Various diagnostic processes may include, withoutlimitation, handpiece integrity, instrument integrity, instrumentattachment integrity, instrument overload, approaching instrumentoverload, frequency lock failure, over-voltage condition, over-currentcondition, over-power condition, voltage sense failure, current sensefailure, audio indication failure, visual indication failure, shortcircuit condition, power delivery failure, or blocking capacitorfailure, for example.

Block 2440 of the processor 1740 may implement a phase control algorithmfor determining and controlling the impedance phase of an electricalload (e.g., the ultrasonic transducer) driven by the generator 1100. Asdiscussed above, by controlling the frequency of the drive signal tominimize or reduce the difference between the determined impedance phaseand an impedance phase setpoint (e.g., 0°), the effects of harmonicdistortion may be minimized or reduced, and the accuracy of the phasemeasurement increased.

The phase control algorithm receives as input the current and voltagefeedback samples stored in the memory location 2180. Prior to their usein the phase control algorithm, the feedback samples may be suitablyscaled and, in certain aspects, processed through a suitable filter 2460(which may be identical to filter 2320) to remove noise resulting fromthe data acquisition process and induced harmonic components, forexample. The filtered voltage and current samples may thereforesubstantially represent the fundamental frequency of the generator'sdrive output signal.

At block 2480 of the phase control algorithm, the current through themotional branch of the ultrasonic transducer is determined. Thisdetermination may be identical to that described above in connectionwith block 2220 of the pre-distortion algorithm. The output of block2480 may thus be, for each set of stored current and voltage feedbacksamples associated with a LUT sample, a motional branch current sample.

At block 2500 of the phase control algorithm, impedance phase isdetermined based on the synchronized input of motional branch currentsamples determined at block 2480 and corresponding voltage feedbacksamples. In certain aspects, the impedance phase is determined as theaverage of the impedance phase measured at the rising edge of thewaveforms and the impedance phase measured at the falling edge of thewaveforms.

At block 2520 of the of the phase control algorithm, the value of theimpedance phase determined at block 2220 is compared to phase setpoint2540 to determine a difference, or phase error, between the comparedvalues.

At block 2560 (FIG. 19A) of the phase control algorithm, based on avalue of phase error determined at block 2520 and the impedancemagnitude determined at block 2420, a frequency output for controllingthe frequency of the drive signal is determined. The value of thefrequency output may be continuously adjusted by the block 2560 andtransferred to a DDS control block 2680 (discussed below) in order tomaintain the impedance phase determined at block 2500 at the phasesetpoint (e.g., zero phase error). In certain aspects, the impedancephase may be regulated to a 0° phase setpoint. In this way, any harmonicdistortion will be centered about the crest of the voltage waveform,enhancing the accuracy of phase impedance determination.

Block 2580 of the processor 1740 may implement an algorithm formodulating the current amplitude of the drive signal in order to controlthe drive signal current, voltage and power in accordance with userspecified setpoints, or in accordance with requirements specified byother processes or algorithms implemented by the generator 1100. Controlof these quantities may be realized, for example, by scaling the LUTsamples in the LUT 2280 and/or by adjusting the full-scale outputvoltage of the DAC 1680 (which supplies the input to the power amplifier1620) via a DAC 1860. Block 2600 (which may be implemented as a PIDcontroller in certain aspects) may receive, as input, current feedbacksamples (which may be suitably scaled and filtered) from the memorylocation 2180. The current feedback samples may be compared to a“current demand” I_(d) value dictated by the controlled variable (e.g.,current, voltage or power) to determine if the drive signal is supplyingthe necessary current. In aspects in which drive signal current is thecontrol variable, the current demand I_(d) may be specified directly bya current setpoint 2620A (I_(sp)). For example, an RMS value of thecurrent feedback data (determined as in block 2340) may be compared touser-specified RMS current setpoint I_(sp) to determine the appropriatecontroller action. If, for example, the current feedback data indicatesan RMS value less than the current setpoint I_(sp), LUT scaling and/orthe full-scale output voltage of the DAC 1680 may be adjusted by theblock 2600 such that the drive signal current is increased. Conversely,block 2600 may adjust LUT scaling and/or the full-scale output voltageof the DAC 1680 to decrease the drive signal current when the currentfeedback data indicates an RMS value greater than the current setpointI_(sp).

In aspects in which the drive signal voltage is the control variable,the current demand I_(d) may be specified indirectly, for example, basedon the current required to maintain a desired voltage setpoint 2620B(V_(sp)) given the load impedance magnitude Z_(m) measured at block 2420(e.g. I_(d)=V_(sp)/Z_(m)). Similarly, in aspects in which drive signalpower is the control variable, the current demand I_(d) may be specifiedindirectly, for example, based on the current required to maintain adesired power setpoint 2620C (P_(sp)) given the voltage V_(rms) measuredat blocks 2360 (e.g. I_(d)=P_(sp)/V_(rms)).

Block 2680 (FIG. 19A) may implement a DDS control algorithm forcontrolling the drive signal by recalling LUT samples stored in the LUT2280. In certain aspects, the DDS control algorithm may be anumerically-controlled oscillator (NCO) algorithm for generating samplesof a waveform at a fixed clock rate using a point (memorylocation)-skipping technique. The NCO algorithm may implement a phaseaccumulator, or frequency-to-phase converter, that functions as anaddress pointer for recalling LUT samples from the LUT 2280. In oneaspect, the phase accumulator may be a D step size, modulo N phaseaccumulator, where D is a positive integer representing a frequencycontrol value, and N is the number of LUT samples in the LUT 2280. Afrequency control value of D=1, for example, may cause the phaseaccumulator to sequentially point to every address of the LUT 2280,resulting in a waveform output replicating the waveform stored in theLUT 2280. When D>1, the phase accumulator may skip addresses in the LUT2280, resulting in a waveform output having a higher frequency.Accordingly, the frequency of the waveform generated by the DDS controlalgorithm may therefore be controlled by suitably varying the frequencycontrol value. In certain aspects, the frequency control value may bedetermined based on the output of the phase control algorithmimplemented at block 2440. The output of block 2680 may supply the inputof DAC 1680, which in turn supplies a corresponding analog signal to aninput of the power amplifier 1620.

Block 2700 of the processor 1740 may implement a switch-mode convertercontrol algorithm for dynamically modulating the rail voltage of thepower amplifier 1620 based on the waveform envelope of the signal beingamplified, thereby improving the efficiency of the power amplifier 1620.In certain aspects, characteristics of the waveform envelope may bedetermined by monitoring one or more signals contained in the poweramplifier 1620. In one aspect, for example, characteristics of thewaveform envelope may be determined by monitoring the minima of a drainvoltage (e.g., a MOSFET drain voltage) that is modulated in accordancewith the envelope of the amplified signal. A minima voltage signal maybe generated, for example, by a voltage minima detector coupled to thedrain voltage. The minima voltage signal may be sampled by ADC 1760,with the output minima voltage samples being received at block 2720 ofthe switch-mode converter control algorithm. Based on the values of theminima voltage samples, block 2740 may control a PWM signal output by aPWM generator 2760, which, in turn, controls the rail voltage suppliedto the power amplifier 1620 by the switch-mode regulator 1700. Incertain aspects, as long as the values of the minima voltage samples areless than a minima target 2780 input into block 2720, the rail voltagemay be modulated in accordance with the waveform envelope ascharacterized by the minima voltage samples. When the minima voltagesamples indicate low envelope power levels, for example, block 2740 maycause a low rail voltage to be supplied to the power amplifier 1620,with the full rail voltage being supplied only when the minima voltagesamples indicate maximum envelope power levels. When the minima voltagesamples fall below the minima target 2780, block 2740 may cause the railvoltage to be maintained at a minimum value suitable for ensuring properoperation of the power amplifier 1620.

In some aspects, an electrical circuit can be used to drive bothultrasonic transducers and RF electrodes interchangeably If drivensimultaneously, filter circuits may be provided to select either theultrasonic waveform or the RF waveform. Such filtering techniques aredescribed in commonly owned U.S. Pat. Pub. No. US-2017-0086910-A1,titled TECHNIQUES FOR CIRCUIT TOPOLOGIES FOR COMBINED GENERATOR, whichis herein incorporated by reference in its entirety.

FIG. 20 is a schematic diagram of a control circuit 3200, such ascontrol circuit 3212, in accordance with at least one aspect of thepresent disclosure. The control circuit 3200 is located within a housingof the battery assembly. The battery assembly is the energy source for avariety of local power supplies 3215. The control circuit comprises amain processor 3214 coupled via an interface master 3218 to variousdownstream circuits by way of outputs SCL-A and SDA-A, SCL-B and SDA-B,SCL-C and SDA-C, for example. In one aspect, the interface master 3218is a general purpose serial interface such as an I²C serial interface.The main processor 3214 also is configured to drive switches 3224through general purposes input/output (GPIO) 3220, a display 3226 (e.g.,and LCD display), and various indicators 3228 through GPIO 3222. Awatchdog processor 3216 is provided to control the main processor 3214.A switch 3230 is provided in series with a battery 3211 to activate thecontrol circuit 3212 upon insertion of the battery assembly into ahandle assembly of a surgical instrument.

The main processor 3214 comprises a memory for storing tables ofdigitized drive signals or waveforms that are transmitted to anelectrical circuit that may be used for driving an ultrasonictransducer, for example. In other aspects, the main processor 3214 maygenerate a digital waveform and transmit it to the electrical circuit ormay store the digital waveform for later transmission to the electricalcircuit. The main processor 3214 also may provide RF drive by way ofoutput terminals SCL-B, SDA-B and various sensors (e.g., Hall-effectsensors, magneto-rheological fluid (MRF) sensors, etc.) by way of outputterminals SCL-C, SDA-C. In one aspect, the main processor 3214 isconfigured to sense the presence of ultrasonic drive circuitry and/or RFdrive circuitry to enable appropriate software and user interfacefunctionality.

In one aspect, the main processor 3214 may be an LM 4F230H5QR, availablefrom Texas Instruments, for example. In at least one example, the TexasInstruments LM4F230H5QR is an ARM Cortex-M4F Processor Core comprisingon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), internal read-only memory (ROM) loaded withStellarisWare® software, 2 KB electrically erasable programmableread-only memory (EEPROM), one or more pulse width modulation (PWM)modules, one or more quadrature encoder inputs (QED analog, one or more12-bit Analog-to-Digital Converters (ADC) with 12 analog input channels,among other features that are readily available from the productdatasheet. Other processors may be readily substituted and, accordingly,the present disclosure should not be limited in this context.

Modular Battery Powered Handheld Surgical Instrument With MultistageGenerator Circuits

In another aspect, the present disclosure provides a modular batterypowered handheld surgical instrument with multistage generator circuits.Disclosed is a surgical instrument that includes a battery assembly, ahandle assembly, and a shaft assembly where the battery assembly and theshaft assembly are configured to mechanically and electrically connectto the handle assembly. The battery assembly includes a control circuitconfigured to generate a digital waveform. The handle assembly includesa first stage circuit configured to receive the digital waveform,convert the digital waveform into an analog waveform, and amplify theanalog waveform. The shaft assembly includes a second stage circuitcoupled to the first stage circuit to receive, amplify, and apply theanalog waveform to a load.

In one aspect, the present disclosure provides a surgical instrument,comprising: a battery assembly, comprising a control circuit comprisinga battery, a memory coupled to the battery, and a processor coupled tothe memory and the battery, wherein the processor is configured togenerate a digital waveform; a handle assembly comprising a first stagecircuit coupled to the processor, the first stage circuit comprising adigital-to-analog (DAC) converter and a first stage amplifier circuit,wherein the DAC is configured to receive the digital waveform andconvert the digital waveform into an analog waveform, wherein the firststage amplifier circuit is configured to receive and amplify the analogwaveform; and a shaft assembly comprising a second stage circuit coupledto the first stage amplifier circuit to receive the analog waveform,amplify the analog waveform, and apply the analog waveform to a load;wherein the battery assembly and the shaft assembly are configured tomechanically and electrically connect to the handle assembly.

The load may comprise any one of an ultrasonic transducer, an electrode,or a sensor, or any combinations thereof. The first stage circuit maycomprise a first stage ultrasonic drive circuit and a first stagehigh-frequency current drive circuit. The control circuit may beconfigured to drive the first stage ultrasonic drive circuit and thefirst stage high-frequency current drive circuit independently orsimultaneously. The first stage ultrasonic drive circuit may beconfigured to couple to a second stage ultrasonic drive circuit. Thesecond stage ultrasonic drive circuit may be configured to couple to anultrasonic transducer. The first stage high-frequency current drivecircuit may be configured to couple to a second stage high-frequencydrive circuit. The second stage high-frequency drive circuit may beconfigured to couple to an electrode.

The first stage circuit may comprise a first stage sensor drive circuit.The first stage sensor drive circuit may be configured to a second stagesensor drive circuit. The second stage sensor drive circuit may beconfigured to couple to a sensor.

In another aspect, the present disclosure provides a surgicalinstrument, comprising: a battery assembly, comprising a control circuitcomprising a battery, a memory coupled to the battery, and a processorcoupled to the memory and the battery, wherein the processor isconfigured to generate a digital waveform; a handle assembly comprisinga common first stage circuit coupled to the processor, the common firststage circuit comprising a digital-to-analog (DAC) converter and acommon first stage amplifier circuit, wherein the DAC is configured toreceive the digital waveform and convert the digital waveform into ananalog waveform, wherein the common first stage amplifier circuit isconfigured to receive and amplify the analog waveform; and a shaftassembly comprising a second stage circuit coupled to the common firststage amplifier circuit to receive the analog waveform, amplify theanalog waveform, and apply the analog waveform to a load; wherein thebattery assembly and the shaft assembly are configured to mechanicallyand electrically connect to the handle assembly.

The load may comprise any one of an ultrasonic transducer, an electrode,or a sensor, or any combinations thereof. The common first stage circuitmay be configured to drive ultrasonic, high-frequency current, or sensorcircuits. The common first stage drive circuit may be configured tocouple to a second stage ultrasonic drive circuit, a second stagehigh-frequency drive circuit, or a second stage sensor drive circuit.The second stage ultrasonic drive circuit may be configured to couple toan ultrasonic transducer, the second stage high-frequency drive circuitis configured to couple to an electrode, and the second stage sensordrive circuit is configured to couple to a sensor.

In another aspect, the present disclosure provides a surgicalinstrument, comprising a control circuit comprising a memory coupled toa processor, wherein the processor is configured to generate a digitalwaveform; a handle assembly comprising a common first stage circuitcoupled to the processor, the common first stage circuit configured toreceive the digital waveform, convert the digital waveform into ananalog waveform, and amplify the analog waveform; and a shaft assemblycomprising a second stage circuit coupled to the common first stagecircuit to receive and amplify the analog waveform; wherein the shaftassembly is configured to mechanically and electrically connect to thehandle assembly.

The common first stage circuit may be configured to drive ultrasonic,high-frequency current, or sensor circuits. The common first stage drivecircuit may be configured to couple to a second stage ultrasonic drivecircuit, a second stage high-frequency drive circuit, or a second stagesensor drive circuit. The second stage ultrasonic drive circuit may beconfigured to couple to an ultrasonic transducer, the second stagehigh-frequency drive circuit is configured to couple to an electrode,and the second stage sensor drive circuit is configured to couple to asensor.

FIG. 21 illustrates a generator circuit 3400 partitioned into a firststage circuit 3404 and a second stage circuit 3406, in accordance withat least one aspect of the present disclosure. In one aspect, thesurgical instruments of surgical system 1000 described herein maycomprise a generator circuit 3400 partitioned into multiple stages. Forexample, surgical instruments of surgical system 1000 may comprise thegenerator circuit 3400 partitioned into at least two circuits: the firststage circuit 3404 and the second stage circuit 3406 of amplificationenabling operation of RF energy only, ultrasonic energy only, and/or acombination of RF energy and ultrasonic energy. A combination modularshaft assembly 3414 may be powered by the common first stage circuit3404 located within a handle assembly 3412 and the modular second stagecircuit 3406 integral to the modular shaft assembly 3414. As previouslydiscussed throughout this description in connection with the surgicalinstruments of surgical system 1000, a battery assembly 3410 and theshaft assembly 3414 are configured to mechanically and electricallyconnect to the handle assembly 3412. The end effector assembly isconfigured to mechanically and electrically connect the shaft assembly3414.

Turning now to FIG. 21, the generator circuit 3400 is partitioned intomultiple stages located in multiple modular assemblies of a surgicalinstrument, such as the surgical instruments of surgical system 1000described herein. In one aspect, a control stage circuit 3402 may belocated in the battery assembly 3410 of the surgical instrument. Thecontrol stage circuit 3402 is a control circuit 3200 as described inconnection with FIG. 20. The control circuit 3200 comprises a processor3214, which includes internal memory 3217 (FIG. 21) (e.g., volatile andnon-volatile memory), and is electrically coupled to a battery 3211. Thebattery 3211 supplies power to the first stage circuit 3404, the secondstage circuit 3406, and a third stage circuit 3408, respectively. Aspreviously discussed, the control circuit 3200 generates a digitalwaveform 4300 (FIG. 29) using circuits and techniques described inconnection with FIGS. 27 and 28. Returning to FIG. 21, the digitalwaveform 4300 may be configured to drive an ultrasonic transducer,high-frequency (e.g., RF) electrodes, or a combination thereof eitherindependently or simultaneously. If driven simultaneously, filtercircuits may be provided in the corresponding first stage circuits 3404to select either the ultrasonic waveform or the RF waveform. Suchfiltering techniques are described in commonly owned U.S. Pat. Pub. No.US-2017-0086910-A1, titled TECHNIQUES FOR CIRCUIT TOPOLOGIES FORCOMBINED GENERATOR, which is herein incorporated by reference in itsentirety.

The first stage circuits 3404 (e.g., the first stage ultrasonic drivecircuit 3420, the first stage RF drive circuit 3422, and the first stagesensor drive circuit 3424) are located in a handle assembly 3412 of thesurgical instrument. The control circuit 3200 provides the RF drivesignal to the first stage RF drive circuit 3422 via outputs SCL-B, SDA-Bof the control circuit 3200. The first stage RF drive circuit 3422 isdescribed in detail in connection with FIG. 23. The control circuit 3200provides the sensor drive signal to the first stage sensor drive circuit3424 via outputs SCL-C, SDA-C of the control circuit 3200. Generally,each of the first stage circuits 3404 includes a digital-to-analog (DAC)converter and a first stage amplifier section to drive the second stagecircuits 3406. The outputs of the first stage circuits 3404 are providedto the inputs of the second stage circuits 3406.

The control circuit 3200 is configured to detect which modules areplugged into the control circuit 3200. For example, the control circuit3200 is configured to detect whether the first stage ultrasonic drivecircuit 3420, the first stage RF drive circuit 3422, or the first stagesensor drive circuit 3424 located in the handle assembly 3412 isconnected to the battery assembly 3410. Likewise, each of the firststage circuits 3404 can detect which second stage circuits 3406 areconnected thereto and that information is provided back to the controlcircuit 3200 to determine the type of signal waveform to generate.Similarly, each of the second stage circuits 3406 can detect which thirdstage circuits 3408 or components are connected thereto and thatinformation is provided back to the control circuit 3200 to determinethe type of signal waveform to generate.

In one aspect, the second stage circuits 3406 (e.g., the ultrasonicdrive second stage circuit 3430, the RF drive second stage circuit 3432,and the sensor drive second stage circuit 3434) are located in the shaftassembly 3414 of the surgical instrument. The first stage ultrasonicdrive circuit 3420 provides a signal to the second stage ultrasonicdrive circuit 3430 via outputs US-Left/US-Right. In addition to atransformer, the second stage ultrasonic drive circuit 3430 also mayinclude filter, amplifier, and signal conditioning circuits. The firststage high-frequency (RF) current drive circuit 3422 provides a signalto the second stage RF drive circuit 3432 via outputs RF-Left/RF-Right.In addition to a transformer and blocking capacitors, the second stageRF drive circuit 3432 also may include filter, amplifier, and signalconditioning circuits. The first stage sensor drive circuit 3424provides a signal to the second stage sensor drive circuit 3434 viaoutputs Sensor-1/Sensor-2. The second stage sensor drive circuit 3434may include filter, amplifier, and signal conditioning circuitsdepending on the type of sensor. The outputs of the second stagecircuits 3406 are provided to the inputs of the third stage circuits3408.

In one aspect, the third stage circuits 3408 (e.g., the ultrasonictransducer 1120, the RF electrodes 3074 a, 3074 b, and the sensors 3440)may be located in various assemblies 3416 of the surgical instruments.In one aspect, the second stage ultrasonic drive circuit 3430 provides adrive signal to the ultrasonic transducer 1120 piezoelectric stack. Inone aspect, the ultrasonic transducer 1120 is located in the ultrasonictransducer assembly of the surgical instrument. In other aspects,however, the ultrasonic transducer 1120 may be located in the handleassembly 3412, the shaft assembly 3414, or the end effector. In oneaspect, the second stage RF drive circuit 3432 provides a drive signalto the RF electrodes 3074 a, 3074 b, which are generally located in theend effector portion of the surgical instrument. In one aspect, thesecond stage sensor drive circuit 3434 provides a drive signal tovarious sensors 3440 located throughout the surgical instrument.

FIG. 22 illustrates a generator circuit 3500 partitioned into multiplestages where a first stage circuit 3504 is common to the second stagecircuit 3506, in accordance with at least one aspect of the presentdisclosure. In one aspect, the surgical instruments of surgical system1000 described herein may comprise generator circuit 3500 partitionedinto multiple stages. For example, the surgical instruments of surgicalsystem 1000 may comprise the generator circuit 3500 partitioned into atleast two circuits: the first stage circuit 3504 and the second stagecircuit 3506 of amplification enabling operation of high-frequency (RF)energy only, ultrasonic energy only, and/or a combination of RF energyand ultrasonic energy. A combination modular shaft assembly 3514 may bepowered by a common first stage circuit 3504 located within the handleassembly 3512 and a modular second stage circuit 3506 integral to themodular shaft assembly 3514. As previously discussed throughout thisdescription in connection with the surgical instruments of surgicalsystem 1000, a battery assembly 3510 and the shaft assembly 3514 areconfigured to mechanically and electrically connect to the handleassembly 3512. The end effector assembly is configured to mechanicallyand electrically connect the shaft assembly 3514.

As shown in the example of FIG. 22, the battery assembly 3510 portion ofthe surgical instrument comprises a first control circuit 3502, whichincludes the control circuit 3200 previously described. The handleassembly 3512, which connects to the battery assembly 3510, comprises acommon first stage drive circuit 3420. As previously discussed, thefirst stage drive circuit 3420 is configured to drive ultrasonic,high-frequency (RF) current, and sensor loads. The output of the commonfirst stage drive circuit 3420 can drive any one of the second stagecircuits 3506 such as the second stage ultrasonic drive circuit 3430,the second stage high-frequency (RF) current drive circuit 3432, and/orthe second stage sensor drive circuit 3434. The common first stage drivecircuit 3420 detects which second stage circuit 3506 is located in theshaft assembly 3514 when the shaft assembly 3514 is connected to thehandle assembly 3512. Upon the shaft assembly 3514 being connected tothe handle assembly 3512, the common first stage drive circuit 3420determines which one of the second stage circuits 3506 (e.g., the secondstage ultrasonic drive circuit 3430, the second stage RF drive circuit3432, and/or the second stage sensor drive circuit 3434) is located inthe shaft assembly 3514. The information is provided to the controlcircuit 3200 located in the handle assembly 3512 in order to supply asuitable digital waveform 4300 (FIG. 29) to the second stage circuit3506 to drive the appropriate load, e.g., ultrasonic, RF, or sensor. Itwill be appreciated that identification circuits may be included invarious assemblies 3516 in third stage circuit 3508 such as theultrasonic transducer 1120, the electrodes 3074 a, 3074 b, or thesensors 3440. Thus, when a third stage circuit 3508 is connected to asecond stage circuit 3506, the second stage circuit 3506 knows the typeof load that is required based on the identification information.

FIG. 23 is a schematic diagram of one aspect of an electrical circuit3600 configured to drive a high-frequency current (RF), in accordancewith at least one aspect of the present disclosure. The electricalcircuit 3600 comprises an analog multiplexer 3680. The analogmultiplexer 3680 multiplexes various signals from the upstream channelsSCL-A, SDA-A such as RF, battery, and power control circuit. A currentsensor 3682 is coupled in series with the return or ground leg of thepower supply circuit to measure the current supplied by the powersupply. A field effect transistor (FET) temperature sensor 3684 providesthe ambient temperature. A pulse width modulation (PWM) watchdog timer3688 automatically generates a system reset if the main program neglectsto periodically service it. It is provided to automatically reset theelectrical circuit 3600 when it hangs or freezes because of a softwareor hardware fault. It will be appreciated that the electrical circuit3600 may be configured for driving RF electrodes or for driving theultrasonic transducer 1120 as described in connection with FIG. 29, forexample. Accordingly, with reference now back to FIG. 23, the electricalcircuit 3600 can be used to drive both ultrasonic and RF electrodesinterchangeably.

A drive circuit 3686 provides Left and Right RF energy outputs. Adigital signal that represents the signal waveform is provided to theSCL-A, SDA-A inputs of the analog multiplexer 3680 from a controlcircuit, such as the control circuit 3200 (FIG. 20). A digital-to-analogconverter 3690 (DAC) converts the digital input to an analog output todrive a PWM circuit 3692 coupled to an oscillator 3694. The PWM circuit3692 provides a first signal to a first gate drive circuit 3696 acoupled to a first transistor output stage 3698 a to drive a first RF+(Left) energy output. The PWM circuit 3692 also provides a second signalto a second gate drive circuit 3696 b coupled to a second transistoroutput stage 3698 b to drive a second RF− (Right) energy output. Avoltage sensor 3699 is coupled between the RF Left/RF output terminalsto measure the output voltage. The drive circuit 3686, the first andsecond drive circuits 3696 a, 3696 b, and the first and secondtransistor output stages 3698 a, 3698 b define a first stage amplifiercircuit. In operation, the control circuit 3200 (FIG. 20) generates adigital waveform 4300 (FIG. 29) employing circuits such as directdigital synthesis (DDS) circuits 4100, 4200 (FIGS. 27 and 28). The DAC3690 receives the digital waveform 4300 and converts it into an analogwaveform, which is received and amplified by the first stage amplifiercircuit.

FIG. 24 is a schematic diagram of the transformer 3700 coupled to theelectrical circuit 3600 shown in FIG. 23, in accordance with at leastone aspect of the present disclosure. The RF+/RF input terminals(primary winding) of the transformer 3700 are electrically coupled tothe RF Left/RF output terminals of the electrical circuit 3600. One sideof the secondary winding is coupled in series with first and secondblocking capacitors 3706, 3708. The second blocking capacitor is coupledto the second stage RF drive circuit 3774 a positive terminal. The otherside of the secondary winding is coupled to the second stage RF drivecircuit 3774 b negative terminal. The second stage RF drive circuit 3774a positive output is coupled to the ultrasonic blade and the secondstage RF drive circuit 3774 b negative ground terminal is coupled to anouter tube. In one aspect, a transformer has a turns-ratio of n₁:n₂ of1:50.

FIG. 25 is a schematic diagram of a circuit 3800 comprising separatepower sources for high power energy/drive circuits and low powercircuits, in accordance with at least one aspect of the presentdisclosure. A power supply 3812 includes a primary battery packcomprising first and second primary batteries 3815, 3817 (e.g., Li-ionbatteries) that are connected into the circuit 3800 by a switch 3818 anda secondary battery pack comprising a secondary battery 3820 that isconnected into the circuit by a switch 3823 when the power supply 3812is inserted into the battery assembly. The secondary battery 3820 is asag preventing battery that has componentry resistant to gamma or otherradiation sterilization. For instance, a switch mode power supply 3827and optional charge circuit within the battery assembly can beincorporated to allow the secondary battery 3820 to reduce the voltagesag of the primary batteries 3815, 3817. This guarantees full chargedcells at the beginning of a surgery that are easy to introduce into thesterile field. The primary batteries 3815, 3817 can be used to powermotor control circuits 3826 and energy circuits 3832 directly. The motorcontrol circuits 3826 are configured to control a motor, such as motor3829. The power supply/battery pack 3812 may comprise a dual typebattery assembly including primary Li-ion batteries 3815, 3817 andsecondary NiMH batteries 3820 with dedicated energy cells 3820 tocontrol handle electronics circuits 3830 from dedicated energy cells3815, 3817 to run the motor control circuits 3826 and the energycircuits 3832. In this case the circuit 3810 pulls from the secondarybatteries 3820 involved in driving the handle electronics circuits 3830when the primary batteries 3815, 3817 involved in driving the energycircuits 3832 and/or motor control circuits 3826 are dropping low. Inone various aspect, the circuit 3810 may include a one way diode thatwould not allow for current to flow in the opposite direction (e.g.,from the batteries involved in driving the energy and/or motor controlcircuits to the batteries involved in driving the electronics circuits).

Additionally, a gamma friendly charge circuit may be provided thatincludes a switch mode power supply 3827 using diodes and vacuum tubecomponents to minimize voltage sag at a predetermined level. With theinclusion of a minimum sag voltage that is a division of the NiMHvoltages (3 NiMH cells) the switch mode power supply 3827 could beeliminated. Additionally a modular system may be provided wherein theradiation hardened components are located in a module, making the modulesterilizable by radiation sterilization. Other non-radiation hardenedcomponents may be included in other modular components and connectionsmade between the modular components such that the componentry operatestogether as if the components were located together on the same circuitboard. If only two NiMH cells are desired the switch mode power supply3827 based on diodes and vacuum tubes allows for sterilizableelectronics within the disposable primary battery pack.

Turning now to FIG. 26, there is shown a control circuit 3900 foroperating a battery 3901 powered RF generator circuit 3902 for use witha surgical instrument, in accordance with at least one aspect of thepresent disclosure. The surgical instrument is configured to use bothultrasonic vibration and high-frequency current to carry out surgicalcoagulation/cutting treatments on living tissue, and uses high-frequencycurrent to carry out a surgical coagulation treatment on living tissue.

FIG. 26 illustrates the control circuit 3900 that allows a dualgenerator system to switch between the RF generator circuit 3902 and theultrasonic generator circuit 3920 energy modalities for a surgicalinstrument of the surgical system 1000. In one aspect, a currentthreshold in an RF signal is detected. When the impedance of the tissueis low the high-frequency current through tissue is high when RF energyis used as the treatment source for the tissue. In accordance with atleast one aspect, a visual indicator 3912 or light located on thesurgical instrument of surgical system 1000 may be configured to be inan on-state during this high current period. When the current fallsbelow a threshold, the visual indicator 3912 is in an off-state.Accordingly, a phototransistor 3914 may be configured to detect thetransition from an on-state to an off-state and disengages the RF energyas shown in the control circuit 3900 shown in FIG. 26. Therefore, whenthe energy button is released and an energy switch 3926 is opened, thecontrol circuit 3900 is reset and both the RF and ultrasonic generatorcircuits 3902, 3920 are held off.

With reference to FIG. 26, in one aspect, a method of managing an RFgenerator circuit 3902 and ultrasound generator circuit 3920 isprovided. The RF generator circuit 3902 and/or the ultrasound generatorcircuit 3920 may be located in the handle assembly 1109, the ultrasonictransducer/RF generator assembly 1120, the battery assembly, the shaftassembly 1129, and/or the nozzle, of the multifunction electrosurgicalinstrument 1108, for example. The control circuit 3900 is held in areset state if the energy switch 3926 is off (e.g., open). Thus, whenthe energy switch 3926 is opened, the control circuit 3900 is reset andboth the RF and ultrasonic generator circuits 3902, 3920 are turned off.When the energy switch 3926 is squeezed and the energy switch 3926 isengaged (e.g., closed), RF energy is delivered to the tissue and thevisual indicator 3912 operated by a current sensing step-up transformer3904 will be lit while the tissue impedance is low. The light from thevisual indicator 3912 provides a logic signal to keep the ultrasonicgenerator circuit 3920 in the off state. Once the tissue impedanceincreases above a threshold and the high-frequency current through thetissue decreases below a threshold, the visual indicator 3912 turns offand the light transitions to an off-state. A logic signal generated bythis transition turns off a relay 3908, whereby the RF generator circuit3902 is turned off and the ultrasonic generator circuit 3920 is turnedon, to complete the coagulation and cut cycle.

Still with reference to FIG. 26, in one aspect, the dual generatorcircuit configuration employs the on-board RF generator circuit 3902,which is battery 3901 powered, for one modality and a second, on-boardultrasound generator circuit 3920, which may be on-board in the handleassembly 1109, battery assembly, shaft assembly 1129, nozzle, and/or theultrasonic transducer/RF generator assembly 1120 of the multifunctionelectrosurgical instrument 1108, for example. The ultrasonic generatorcircuit 3920 also is battery 3901 operated. In various aspects, the RFgenerator circuit 3902 and the ultrasonic generator circuit 3920 may bean integrated or separable component of the handle assembly 1109.According to various aspects, having the dual RF/ultrasonic generatorcircuits 3902, 3920 as part of the handle assembly 1109 may eliminatethe need for complicated wiring. The RF/ultrasonic generator circuits3902, 3920 may be configured to provide the full capabilities of anexisting generator while utilizing the capabilities of a cordlessgenerator system simultaneously.

Either type of system can have separate controls for the modalities thatare not communicating with each other. The surgeon activates the RF andUltrasonic separately and at their discretion. Another approach would beto provide fully integrated communication schemes that share buttons,tissue status, instrument operating parameters (such as jaw closure,forces, etc.) and algorithms to manage tissue treatment. Variouscombinations of this integration can be implemented to provide theappropriate level of function and performance.

As discussed above, in one aspect, the control circuit 3900 includes thebattery 3901 powered RF generator circuit 3902 comprising a battery asan energy source. As shown, RF generator circuit 3902 is coupled to twoelectrically conductive surfaces referred to herein as electrodes 3906a, 3906 b (i.e., active electrode 3906 a and return electrode 3906 b)and is configured to drive the electrodes 3906 a, 3906 b with RF energy(e.g., high-frequency current). A first winding 3910 a of the step-uptransformer 3904 is connected in series with one pole of the bipolar RFgenerator circuit 3902 and the return electrode 3906 b. In one aspect,the first winding 3910 a and the return electrode 3906 b are connectedto the negative pole of the bipolar RF generator circuit 3902. The otherpole of the bipolar RF generator circuit 3902 is connected to the activeelectrode 3906 a through a switch contact 3909 of the relay 3908, or anysuitable electromagnetic switching device comprising an armature whichis moved by an electromagnet 3936 to operate the switch contact 3909.The switch contact 3909 is closed when the electromagnet 3936 isenergized and the switch contact 3909 is open when the electromagnet3936 is de-energized. When the switch contact is closed, RF currentflows through conductive tissue (not shown) located between theelectrodes 3906 a, 3906 b. It will be appreciated, that in one aspect,the active electrode 3906 a is connected to the positive pole of thebipolar RF generator circuit 3902.

A visual indicator circuit 3905 comprises the step-up transformer 3904,a series resistor R2, and the visual indicator 3912. The visualindicator 3912 can be adapted for use with the surgical instrument 1108and other electrosurgical systems and tools, such as those describedherein. The first winding 3910 a of the step-up transformer 3904 isconnected in series with the return electrode 3906 b and the secondwinding 3910 b of the step-up transformer 3904 is connected in serieswith the resistor R2 and the visual indicator 3912 comprising a typeNE-2 neon bulb, for example.

In operation, when the switch contact 3909 of the relay 3908 is open,the active electrode 3906 a is disconnected from the positive pole ofthe bipolar RF generator circuit 3902 and no current flows through thetissue, the return electrode 3906 b, and the first winding 3910 a of thestep-up transformer 3904. Accordingly, the visual indicator 3912 is notenergized and does not emit light. When the switch contact 3909 of therelay 3908 is closed, the active electrode 3906 a is connected to thepositive pole of the bipolar RF generator circuit 3902 enabling currentto flow through tissue, the return electrode 3906 b, and the firstwinding 3910 a of the step-up transformer 3904 to operate on tissue, forexample cut and cauterize the tissue.

A first current flows through the first winding 3910 a as a function ofthe impedance of the tissue located between the active and returnelectrodes 3906 a, 3906 b providing a first voltage across the firstwinding 3910 a of the step-up transformer 3904. A stepped up secondvoltage is induced across the second winding 3910 b of the step-uptransformer 3904. The secondary voltage appears across the resistor R2and energizes the visual indicator 3912 causing the neon bulb to lightwhen the current through the tissue is greater than a predeterminedthreshold. It will be appreciated that the circuit and component valuesare illustrative and not limited thereto. When the switch contact 3909of the relay 3908 is closed, current flows through the tissue and thevisual indicator 3912 is turned on.

Turning now to the energy switch 3926 portion of the control circuit3900, when the energy switch 3926 is open position, a logic high isapplied to the input of a first inverter 3928 and a logic low is appliedof one of the two inputs of the AND gate 3932. Thus, the output of theAND gate 3932 is low and a transistor 3934 is off to prevent currentfrom flowing through the winding of the electromagnet 3936. With theelectromagnet 3936 in the de-energized state, the switch contact 3909 ofthe relay 3908 remains open and prevents current from flowing throughthe electrodes 3906 a, 3906 b. The logic low output of the firstinverter 3928 also is applied to a second inverter 3930 causing theoutput to go high and resetting a flip-flop 3918 (e.g., a D-Typeflip-flop). At which time, the Q output goes low to turn off theultrasound generator circuit 3920 circuit and the Q output goes high andis applied to the other input of the AND gate 3932.

When the user presses the energy switch 3926 on the instrument handle toapply energy to the tissue between the electrodes 3906 a, 3906 b, theenergy switch 3926 closes and applies a logic low at the input of thefirst inverter 3928, which applies a logic high to other input of theAND gate 3932 causing the output of the AND gate 3932 to go high andturns on the transistor 3934. In the on state, the transistor 3934conducts and sinks current through the winding of the electromagnet 3936to energize the electromagnet 3936 and close the switch contact 3909 ofthe relay 3908. As discussed above, when the switch contact 3909 isclosed, current can flow through the electrodes 3906 a, 3906 b and thefirst winding 3910 a of the step-up transformer 3904 when tissue islocated between the electrodes 3906 a, 3906 b.

As discussed above, the magnitude of the current flowing through theelectrodes 3906 a, 3906 b depends on the impedance of the tissue locatedbetween the electrodes 3906 a, 3906 b. Initially, the tissue impedanceis low and the magnitude of the current high through the tissue and thefirst winding 3910 a. Consequently, the voltage impressed on the secondwinding 3910 b is high enough to turn on the visual indicator 3912. Thelight emitted by the visual indicator 3912 turns on the phototransistor3914, which pulls the input of an inverter 3916 low and causes theoutput of the inverter 3916 to go high. A high input applied to the CLKof the flip-flop 3918 has no effect on the Q or the Q outputs of theflip-flop 3918 and Q output remains low and the Q output remains high.Accordingly, while the visual indicator 3912 remains energized, theultrasound generator circuit 3920 is turned OFF and an ultrasonictransducer 3922 and an ultrasonic blade 3924 of the multifunctionelectrosurgical instrument are not activated.

As the tissue between the electrodes 3906 a, 3906 b dries up, due to theheat generated by the current flowing through the tissue, the impedanceof the tissue increases and the current therethrough decreases. When thecurrent through the first winding 3910 a decreases, the voltage acrossthe second winding 3910 b also decreases and when the voltage dropsbelow a minimum threshold required to operate the visual indicator 3912,the visual indicator 3912 and the phototransistor 3914 turn off. Whenthe phototransistor 3914 turns off, a logic high is applied to the inputof the inverter 3916 and a logic low is applied to the CLK input of theflip-flop 3918 to clock a logic high to the Q output and a logic low tothe Q output. The logic high at the Q output turns on the ultrasoundgenerator circuit 3920 to activate the ultrasonic transducer 3922 andthe ultrasonic blade 3924 to initiate cutting the tissue located betweenthe electrodes 3906 a, 3906 a. Simultaneously or near simultaneouslywith the ultrasound generator circuit 3920 turning on, the Q output ofthe flip-flop 3918 goes low and causes the output of the AND gate 3932to go low and turn off the transistor 3934, thereby de-energizing theelectromagnet 3936 and opening the switch contact 3909 of the relay 3908to cut off the flow of current through the electrodes 3906 a, 3906 b.

While the switch contact 3909 of the relay 3908 is open, no currentflows through the electrodes 3906 a, 3906 b, tissue, and the firstwinding 3910 a of the step-up transformer 3904. Therefore, no voltage isdeveloped across the second winding 3910 b and no current flows throughthe visual indicator 3912.

The state of the Q and the Q outputs of the flip-flop 3918 remain thesame while the user squeezes the energy switch 3926 on the instrumenthandle to maintain the energy switch 3926 closed. Thus, the ultrasonicblade 3924 remains activated and continues cutting the tissue betweenthe jaws of the end effector while no current flows through theelectrodes 3906 a, 3906 b from the bipolar RF generator circuit 3902.When the user releases the energy switch 3926 on the instrument handle,the energy switch 3926 opens and the output of the first inverter 3928goes low and the output of the second inverter 3930 goes high to resetthe flip-flop 3918 causing the Q output to go low and turn off theultrasound generator circuit 3920. At the same time, the Q output goeshigh and the circuit is now in an off state and ready for the user toactuate the energy switch 3926 on the instrument handle to close theenergy switch 3926, apply current to the tissue located between theelectrodes 3906 a, 3906 b, and repeat the cycle of applying RF energy tothe tissue and ultrasonic energy to the tissue as described above.

In one aspect, the ultrasonic or high-frequency current generators ofthe surgical system 1000 may be configured to generate the electricalsignal waveform digitally such that the desired using a predeterminednumber of phase points stored in a lookup table to digitize the waveshape. The phase points may be stored in a table defined in a memory, afield programmable gate array (FPGA), or any suitable non-volatilememory. FIG. 27 illustrates one aspect of a fundamental architecture fora digital synthesis circuit such as a direct digital synthesis (DDS)circuit 4100 configured to generate a plurality of wave shapes for theelectrical signal waveform. The generator software and digital controlsmay command the FPGA to scan the addresses in the lookup table 4104which in turn provides varying digital input values to a DAC circuit4108 that feeds a power amplifier. The addresses may be scannedaccording to a frequency of interest. Using such a lookup table 4104enables generating various types of wave shapes that can be fed intotissue or into a transducer, an RF electrode, multiple transducerssimultaneously, multiple RF electrodes simultaneously, or a combinationof RF and ultrasonic instruments. Furthermore, multiple lookup tables4104 that represent multiple wave shapes can be created, stored, andapplied to tissue from a generator.

The waveform signal may be configured to control at least one of anoutput current, an output voltage, or an output power of an ultrasonictransducer and/or an RF electrode, or multiples thereof (e.g. two ormore ultrasonic transducers and/or two or more RF electrodes). Further,where the surgical instrument comprises an ultrasonic components, thewaveform signal may be configured to drive at least two vibration modesof an ultrasonic transducer of the at least one surgical instrument.Accordingly, a generator may be configured to provide a waveform signalto at least one surgical instrument wherein the waveform signalcorresponds to at least one wave shape of a plurality of wave shapes ina table. Further, the waveform signal provided to the two surgicalinstruments may comprise two or more wave shapes. The table may compriseinformation associated with a plurality of wave shapes and the table maybe stored within the generator. In one aspect or example, the table maybe a direct digital synthesis table, which may be stored in an FPGA ofthe generator. The table may be addressed by anyway that is convenientfor categorizing wave shapes. In accordance with at least one aspect,the table, which may be a direct digital synthesis table, is addressedaccording to a frequency of the waveform signal. Additionally, theinformation associated with the plurality of wave shapes may be storedas digital information in the table.

The analog electrical signal waveform may be configured to control atleast one of an output current, an output voltage, or an output power ofan ultrasonic transducer and/or an RF electrode, or multiples thereof(e.g., two or more ultrasonic transducers and/or two or more RFelectrodes). Further, where the surgical instrument comprises ultrasoniccomponents, the analog electrical signal waveform may be configured todrive at least two vibration modes of an ultrasonic transducer of the atleast one surgical instrument. Accordingly, the generator circuit may beconfigured to provide an analog electrical signal waveform to at leastone surgical instrument wherein the analog electrical signal waveformcorresponds to at least one wave shape of a plurality of wave shapesstored in a lookup table 4104. Further, the analog electrical signalwaveform provided to the two surgical instruments may comprise two ormore wave shapes. The lookup table 4104 may comprise informationassociated with a plurality of wave shapes and the lookup table 4104 maybe stored either within the generator circuit or the surgicalinstrument. In one aspect or example, the lookup table 4104 may be adirect digital synthesis table, which may be stored in an FPGA of thegenerator circuit or the surgical instrument. The lookup table 4104 maybe addressed by anyway that is convenient for categorizing wave shapes.In accordance with at least one aspect, the lookup table 4104, which maybe a direct digital synthesis table, is addressed according to afrequency of the desired analog electrical signal waveform.Additionally, the information associated with the plurality of waveshapes may be stored as digital information in the lookup table 4104.

With the widespread use of digital techniques in instrumentation andcommunications systems, a digitally-controlled method of generatingmultiple frequencies from a reference frequency source has evolved andis referred to as direct digital synthesis. The basic architecture isshown in FIG. 27. In this simplified block diagram, a DDS circuit iscoupled to a processor, controller, or a logic device of the generatorcircuit and to a memory circuit located in the generator circuit of thesurgical system 1000. The DDS circuit 4100 comprises an address counter4102, lookup table 4104, a register 4106, a DAC circuit 4108, and afilter 4112. A stable clock f_(c) is received by the address counter4102 and the register 4106 drives a programmable-read-only-memory (PROM)which stores one or more integral number of cycles of a sinewave (orother arbitrary waveform) in a lookup table 4104. As the address counter4102 steps through memory locations, values stored in the lookup table4104 are written to the register 4106, which is coupled to the DACcircuit 4108. The corresponding digital amplitude of the signal at thememory location of the lookup table 4104 drives the DAC circuit 4108,which in turn generates an analog output signal 4110. The spectralpurity of the analog output signal 4110 is determined primarily by theDAC circuit 4108. The phase noise is basically that of the referenceclock f_(c). The first analog output signal 4110 output from the DACcircuit 4108 is filtered by the filter 4112 and a second analog outputsignal 4114 output by the filter 4112 is provided to an amplifier havingan output coupled to the output of the generator circuit. The secondanalog output signal has a frequency f_(out).

Because the DDS circuit 4100 is a sampled data system, issues involvedin sampling must be considered: quantization noise, aliasing, filtering,etc. For instance, the higher order harmonics of the DAC circuit 4108output frequencies fold back into the Nyquist bandwidth, making themunfilterable, whereas, the higher order harmonics of the output ofphase-locked-loop (PLL) based synthesizers can be filtered. The lookuptable 4104 contains signal data for an integral number of cycles. Thefinal output frequency f_(out) can be changed changing the referenceclock frequency f_(c) or by reprogramming the PROM.

The DDS circuit 4100 may comprise multiple lookup tables 4104 where thelookup table 4104 stores a waveform represented by a predeterminednumber of samples, wherein the samples define a predetermined shape ofthe waveform. Thus multiple waveforms having a unique shape can bestored in multiple lookup tables 4104 to provide different tissuetreatments based on instrument settings or tissue feedback. Examples ofwaveforms include high crest factor RF electrical signal waveforms forsurface tissue coagulation, low crest factor RF electrical signalwaveform for deeper tissue penetration, and electrical signal waveformsthat promote efficient touch-up coagulation. In one aspect, the DDScircuit 4100 can create multiple wave shape lookup tables 4104 andduring a tissue treatment procedure (e.g., “on-the-fly” or in virtualreal time based on user or sensor inputs) switch between different waveshapes stored in separate lookup tables 4104 based on the tissue effectdesired and/or tissue feedback. Accordingly, switching between waveshapes can be based on tissue impedance and other factors, for example.In other aspects, the lookup tables 4104 can store electrical signalwaveforms shaped to maximize the power delivered into the tissue percycle (i.e., trapezoidal or square wave). In other aspects, the lookuptables 4104 can store wave shapes synchronized in such way that theymake maximizing power delivery by the multifunction surgical instrumentof surgical system 1000 while delivering RF and ultrasonic drivesignals. In yet other aspects, the lookup tables 4104 can storeelectrical signal waveforms to drive ultrasonic and RF therapeutic,and/or sub-therapeutic, energy simultaneously while maintainingultrasonic frequency lock. Custom wave shapes specific to differentinstruments and their tissue effects can be stored in the non-volatilememory of the generator circuit or in the non-volatile memory (e.g.,EEPROM) of the surgical system 1000 and be fetched upon connecting themultifunction surgical instrument to the generator circuit. An exampleof an exponentially damped sinusoid, as used in many high crest factor“coagulation” waveforms is shown in FIG. 29.

A more flexible and efficient implementation of the DDS circuit 4100employs a digital circuit called a Numerically Controlled Oscillator(NCO). A block diagram of a more flexible and efficient digitalsynthesis circuit such as a DDS circuit 4200 is shown in FIG. 28. Inthis simplified block diagram, a DDS circuit 4200 is coupled to aprocessor, controller, or a logic device of the generator and to amemory circuit located either in the generator or in any of the surgicalinstruments of surgical system 1000. The DDS circuit 4200 comprises aload register 4202, a parallel delta phase register 4204, an addercircuit 4216, a phase register 4208, a lookup table 4210(phase-to-amplitude converter), a DAC circuit 4212, and a filter 4214.The adder circuit 4216 and the phase register 4208 form part of a phaseaccumulator 4206. A clock frequency f_(c) is applied to the phaseregister 4208 and a DAC circuit 4212. The load register 4202 receives atuning word that specifies output frequency as a fraction of thereference clock frequency signal f_(c). The output of the load register4202 is provided to the parallel delta phase register 4204 with a tuningword M.

The DDS circuit 4200 includes a sample clock that generates the clockfrequency f_(c), the phase accumulator 4206, and the lookup table 4210(e.g., phase to amplitude converter). The content of the phaseaccumulator 4206 is updated once per clock cycle f_(c). When time thephase accumulator 4206 is updated, the digital number, M, stored in theparallel delta phase register 4204 is added to the number in the phaseregister 4208 by the adder circuit 4216. Assuming that the number in theparallel delta phase register 4204 is 00 . . . 01 and that the initialcontents of the phase accumulator 4206 is 00 . . . 00. The phaseaccumulator 4206 is updated by 00 . . . 01 per clock cycle. If the phaseaccumulator 4206 is 32-bits wide, 232 clock cycles (over 4 billion) arerequired before the phase accumulator 4206 returns to 00 . . . 00, andthe cycle repeats.

A truncated output 4218 of the phase accumulator 4206 is provided to aphase-to amplitude converter lookup table 4210 and the output of thelookup table 4210 is coupled to a DAC circuit 4212. The truncated output4218 of the phase accumulator 4206 serves as the address to a sine (orcosine) lookup table. An address in the lookup table corresponds to aphase point on the sinewave from 0° to 360°. The lookup table 4210contains the corresponding digital amplitude information for onecomplete cycle of a sinewave. The lookup table 4210 therefore maps thephase information from the phase accumulator 4206 into a digitalamplitude word, which in turn drives the DAC circuit 4212. The output ofthe DAC circuit is a first analog signal 4220 and is filtered by afilter 4214. The output of the filter 4214 is a second analog signal4222, which is provided to a power amplifier coupled to the output ofthe generator circuit.

In one aspect, the electrical signal waveform may be digitized into 1024(210) phase points, although the wave shape may be digitized is anysuitable number of 2 n phase points ranging from 256 (28) to281,474,976,710,656 (248), where n is a positive integer, as shown inTABLE 1. The electrical signal waveform may be expressed asA_(n)(θ_(n)), where a normalized amplitude A_(n) at a point n isrepresented by a phase angle θ_(n) is referred to as a phase point atpoint n. The number of discrete phase points n determines the tuningresolution of the DDS circuit 4200 (as well as the DDS circuit 4100shown in FIG. 21).

TABLE 1 specifies the electrical signal waveform digitized into a numberof phase points.

TABLE 1 N Number of Phase Points 2^(n)  8 256 10 1,024 12 4,096 1416,384 16 65,536 18 262,144 20 1,048,576 22 4,194,304 24 16,777,216 2667,108,864 28 268,435,456 . . . . . . 32 4,294,967,296 . . . . . . 48281,474,976,710,656 . . . . . .

The generator circuit algorithms and digital control circuits scan theaddresses in the lookup table 4210, which in turn provides varyingdigital input values to the DAC circuit 4212 that feeds the filter 4214and the power amplifier. The addresses may be scanned according to afrequency of interest. Using the lookup table enables generating varioustypes of shapes that can be converted into an analog output signal bythe DAC circuit 4212, filtered by the filter 4214, amplified by thepower amplifier coupled to the output of the generator circuit, and fedto the tissue in the form of RF energy or fed to an ultrasonictransducer and applied to the tissue in the form of ultrasonicvibrations which deliver energy to the tissue in the form of heat. Theoutput of the amplifier can be applied to an RF electrode, multiple RFelectrodes simultaneously, an ultrasonic transducer, multiple ultrasonictransducers simultaneously, or a combination of RF and ultrasonictransducers, for example. Furthermore, multiple wave shape tables can becreated, stored, and applied to tissue from a generator circuit.

With reference back to FIG. 21, for n=32, and M=1, the phase accumulator4206 steps through 232 possible outputs before it overflows andrestarts. The corresponding output wave frequency is equal to the inputclock frequency divided by 232. If M=2, then the phase register 1708“rolls over” twice as fast, and the output frequency is doubled. Thiscan be generalized as follows.

For a phase accumulator 4206 configured to accumulate n-bits (ngenerally ranges from 24 to 32 in most DDS systems, but as previouslydiscussed n may be selected from a wide range of options), there are2^(n) possible phase points. The digital word in the delta phaseregister, M, represents the amount the phase accumulator is incrementedper clock cycle. If f_(c) is the clock frequency, then the frequency ofthe output sinewave is equal to:

$f_{0} = \frac{M \cdot f_{c}}{2^{n}}$

The above equation is known as the DDS is known as the DDS “tuningequation.” Note that the frequency resolution of the system is equal to

$\frac{f_{o}}{2^{n}}.$For n=32, the resolution is greater than one part in four billion. Inone aspect of the DDS circuit 4200, not all of the bits out of the phaseaccumulator 4206 are passed on to the lookup table 4210, but aretruncated, leaving only the first 13 to 15 most significant bits (MSBs),for example. This reduces the size of the lookup table 4210 and does notaffect the frequency resolution. The phase truncation only adds a smallbut acceptable amount of phase noise to the final output.

The electrical signal waveform may be characterized by a current,voltage, or power at a predetermined frequency. Further, where any oneof the surgical instruments of surgical system 1000 comprises ultrasoniccomponents, the electrical signal waveform may be configured to drive atleast two vibration modes of an ultrasonic transducer of the at leastone surgical instrument. Accordingly, the generator circuit may beconfigured to provide an electrical signal waveform to at least onesurgical instrument wherein the electrical signal waveform ischaracterized by a predetermined wave shape stored in the lookup table4210 (or lookup table 4104 FIG. 27). Further, the electrical signalwaveform may be a combination of two or more wave shapes. The lookuptable 4210 may comprise information associated with a plurality of waveshapes. In one aspect or example, the lookup table 4210 may be generatedby the DDS circuit 4200 and may be referred to as a direct digitalsynthesis table. DDS works by first storing a large repetitive waveformin onboard memory. A cycle of a waveform (sine, triangle, square,arbitrary) can be represented by a predetermined number of phase pointsas shown in TABLE 1 and stored into memory. Once the waveform is storedinto memory, it can be generated at very precise frequencies. The directdigital synthesis table may be stored in a non-volatile memory of thegenerator circuit and/or may be implemented with a FPGA circuit in thegenerator circuit. The lookup table 4210 may be addressed by anysuitable technique that is convenient for categorizing wave shapes.According to one aspect, the lookup table 4210 is addressed according toa frequency of the electrical signal waveform. Additionally, theinformation associated with the plurality of wave shapes may be storedas digital information in a memory or as part of the lookup table 4210.

In one aspect, the generator circuit may be configured to provideelectrical signal waveforms to at least two surgical instrumentssimultaneously. The generator circuit also may be configured to providethe electrical signal waveform, which may be characterized two or morewave shapes, via an output channel of the generator circuit to the twosurgical instruments simultaneously. For example, in one aspect theelectrical signal waveform comprises a first electrical signal to drivean ultrasonic transducer (e.g., ultrasonic drive signal), a second RFdrive signal, and/or a combination thereof. In addition, an electricalsignal waveform may comprise a plurality of ultrasonic drive signals, aplurality of RF drive signals, and/or a combination of a plurality ofultrasonic and RF drive signals.

In addition, a method of operating the generator circuit according tothe present disclosure comprises generating an electrical signalwaveform and providing the generated electrical signal waveform to anyone of the surgical instruments of surgical system 1000, wheregenerating the electrical signal waveform comprises receivinginformation associated with the electrical signal waveform from amemory. The generated electrical signal waveform comprises at least onewave shape. Furthermore, providing the generated electrical signalwaveform to the at least one surgical instrument comprises providing theelectrical signal waveform to at least two surgical instrumentssimultaneously.

The generator circuit as described herein may allow for the generationof various types of direct digital synthesis tables. Examples of waveshapes for RF/Electrosurgery signals suitable for treating a variety oftissue generated by the generator circuit include RF signals with a highcrest factor (which may be used for surface coagulation in RF mode), alow crest factor RF signals (which may be used for deeper tissuepenetration), and waveforms that promote efficient touch-up coagulation.The generator circuit also may generate multiple wave shapes employing adirect digital synthesis lookup table 4210 and, on the fly, can switchbetween particular wave shapes based on the desired tissue effect.Switching may be based on tissue impedance and/or other factors.

In addition to traditional sine/cosine wave shapes, the generatorcircuit may be configured to generate wave shape(s) that maximize thepower into tissue per cycle (i.e., trapezoidal or square wave). Thegenerator circuit may provide wave shape(s) that are synchronized tomaximize the power delivered to the load when driving RF and ultrasonicsignals simultaneously and to maintain ultrasonic frequency lock,provided that the generator circuit includes a circuit topology thatenables simultaneously driving RF and ultrasonic signals. Further,custom wave shapes specific to instruments and their tissue effects canbe stored in a non-volatile memory (NVM) or an instrument EEPROM and canbe fetched upon connecting any one of the surgical instruments ofsurgical system 1000 to the generator circuit.

The DDS circuit 4200 may comprise multiple lookup tables 4104 where thelookup table 4210 stores a waveform represented by a predeterminednumber of phase points (also may be referred to as samples), wherein thephase points define a predetermined shape of the waveform. Thus multiplewaveforms having a unique shape can be stored in multiple lookup tables4210 to provide different tissue treatments based on instrument settingsor tissue feedback. Examples of waveforms include high crest factor RFelectrical signal waveforms for surface tissue coagulation, low crestfactor RF electrical signal waveform for deeper tissue penetration, andelectrical signal waveforms that promote efficient touch-up coagulation.In one aspect, the DDS circuit 4200 can create multiple wave shapelookup tables 4210 and during a tissue treatment procedure (e.g.,“on-the-fly” or in virtual real time based on user or sensor inputs)switch between different wave shapes stored in different lookup tables4210 based on the tissue effect desired and/or tissue feedback.Accordingly, switching between wave shapes can be based on tissueimpedance and other factors, for example. In other aspects, the lookuptables 4210 can store electrical signal waveforms shaped to maximize thepower delivered into the tissue per cycle (i.e., trapezoidal or squarewave). In other aspects, the lookup tables 4210 can store wave shapessynchronized in such way that they make maximizing power delivery by anyone of the surgical instruments of surgical system 1000 when deliveringRF and ultrasonic drive signals. In yet other aspects, the lookup tables4210 can store electrical signal waveforms to drive ultrasonic and RFtherapeutic, and/or sub-therapeutic, energy simultaneously whilemaintaining ultrasonic frequency lock. Generally, the output wave shapemay be in the form of a sine wave, cosine wave, pulse wave, square wave,and the like. Nevertheless, the more complex and custom wave shapesspecific to different instruments and their tissue effects can be storedin the non-volatile memory of the generator circuit or in thenon-volatile memory (e.g., EEPROM) of the surgical instrument and befetched upon connecting the surgical instrument to the generatorcircuit. One example of a custom wave shape is an exponentially dampedsinusoid as used in many high crest factor “coagulation” waveforms, asshown in FIG. 23.

FIG. 29 illustrates one cycle of a discrete time digital electricalsignal waveform 4300, in accordance with at least one aspect of thepresent disclosure of an analog waveform 4304 (shown superimposed overthe discrete time digital electrical signal waveform 4300 for comparisonpurposes). The horizontal axis represents Time (t) and the vertical axisrepresents digital phase points. The digital electrical signal waveform4300 is a digital discrete time version of the desired analog waveform4304, for example. The digital electrical signal waveform 4300 isgenerated by storing an amplitude phase point 4302 that represents theamplitude per clock cycle T_(clk) over one cycle or period T_(o). Thedigital electrical signal waveform 4300 is generated over one periodT_(o) by any suitable digital processing circuit. The amplitude phasepoints are digital words stored in a memory circuit. In the exampleillustrated in FIGS. 27, 28, the digital word is a six-bit word that iscapable of storing the amplitude phase points with a resolution of 26 or64 bits. It will be appreciated that the examples shown in FIGS. 27, 28is for illustrative purposes and in actual implementations theresolution can be much higher. The digital amplitude phase points 4302over one cycle T_(o) are stored in the memory as a string of stringwords in a lookup table 4104, 4210 as described in connection with FIGS.27, 28, for example. To generate the analog version of the analogwaveform 4304, the amplitude phase points 4302 are read sequentiallyfrom the memory from 0 to T_(o) per clock cycle T_(clk) and areconverted by a DAC circuit 4108, 4212, also described in connection withFIGS. 27, 28. Additional cycles can be generated by repeatedly readingthe amplitude phase points 4302 of the digital electrical signalwaveform 4300 the from 0 to T_(o) for as many cycles or periods as maybe desired. The smooth analog version of the analog waveform 4304 isachieved by filtering the output of the DAC circuit 4108, 4212 by afilter 4112, 4214 (FIGS. 27 and 28). The filtered analog output signal4114, 4222 (FIGS. 27 and 28) is applied to the input of a poweramplifier.

Advanced RF Energy Device Including Nerve Stimulation Signal withTherapeutic Waveforms

As disclosed above, in some surgical procedures, a medical professionalmay employ an electrosurgical device to seal or cut tissues such asblood vessels. Such devices effect a medical therapy by passingelectrical energy, for example current at radiofrequencies (RF), throughthe tissue to be treated. Some electrosurgical devices are termedbipolar devices in that both an electrode to source the electricalenergy (the active electrode) and a return electrode are housed in thesame surgical probe. It will be appreciated that a surgical probe maycomprise a handpiece or a robotically controlled instrument or acombination thereof.

Alternative devices may be termed monopolar devices. In such devices,only the active electrode is housed in the surgical probe. Theelectrical current entering the patient's tissue may return to theelectrical energy generator via an electrical path through the gurney onwhich the patient reposes or through a specific return electrode pad. Insome aspects, the patient may repose on the electrode pad, or theelectrode pad may be placed on the patient at a location close to thesurgical site where the surgical probe is deployed. It may be recognizedthat the current path through a patient undergoing a procedure using amonopolar device may be less well characterized than the current paththrough a patient undergoing a procedure using a bipolar device.Consequently, some non-target tissue may be inadvertently cauterized,cut, or otherwise damaged by a monopolar electrosurgical device. Suchunintended injury to excitable tissue may result in the patientexperiencing muscle weakness, pain, numbness, paralysis and/or otherundesired outcomes.

It is therefore desirable that a monopolar electrosurgical deviceincorporate features to determine if the device is close enough toexcitable tissue to cause inadvertent injury. Such features may be usedby one or more subsystems of the electrosurgical device as a basis fornotifying the medical professional of the proximity of such tissue tothe monopolar electrode. Additionally, such features may be used by oneor more subsystems of an intelligent electrosurgical device to reduce oreliminate the amount of therapeutic energy delivered to tissue deemed toclose to non-target excitable tissue. In some intelligent medicaldevices that combine electrosurgical (RF) with ultrasonic therapeuticmodes, features to determine if the device is close enough to excitabletissue to cause inadvertent injury when the device is operating in theelectrosurgical (RF) mode may result in the device switching to theultrasonic mode.

Electrosurgical devices for applying electrical energy to tissue inorder to treat and/or destroy the tissue are also finding increasinglywidespread applications in surgical procedures. An electrosurgicaldevice typically includes a surgical probe, an instrument having adistally-mounted end effector (e.g., one or more electrodes). The endeffector can be positioned against the tissue such that electricalcurrent is introduced into the tissue. Electrosurgical devices can beconfigured for bipolar or monopolar operation. During bipolar operation,current is introduced into and returned from the tissue by active andreturn electrodes, respectively, of the end effector. During monopolaroperation, current is introduced into the tissue by an active electrodelocated at a distal end of the surgical probe and returned through areturn electrode (e.g., a grounding pad) separately located on apatient's body. Heat generated by the current flowing through the tissuemay form hemostatic seals within the tissue and/or between tissues andthus may be particularly useful for sealing blood vessels, for example.The end effector of an electrosurgical device also may include a cuttingmember that is movable relative to the tissue and the electrodes totransect the tissue.

FIG. 30 depicts a typical monopolar electrosurgical system 136000. Theelectrosurgical system 136000 can include a controller 136010, agenerator 136012, an electrosurgical instrument 136015, and a return pad136020 which includes one or more return electrodes. Typically, thegenerator 136012 may source an electrical signal to the electrosurgicalinstrument 136015 along a first conducting electrical path 136017 andmay receive a return signal from the one or more return electrodes alonga second conducting electrical path 136023. FIG. 30 depicts an exampleof a health care professional 136025 treating a patient 136027 using anelectrosurgical instrument 136015 such as an active monopolar electrode.

FIG. 31 is a schematic block diagram of the patient and electricalcomponents depicted in FIG. 30. The generator 136012 may be a separatecomponent from the controller 136010 or the controller 136010 mayinclude the electrical generator 136012. The controller 136010 maycontrol the operation of the generator 136012, including controlling anelectrical output thereof. As disclosed below, the controller 136010 maycontrol one or more output waveforms of the electrical generator 136012including the control of a variety of characteristics includingamplitude characteristics, frequency characteristics, and phasecharacteristics of the output signal of the electrical generator 136012.The controller 136010 may further receive signals from any number ofadditional components including, without limitation, manual controlactuators (switches, push buttons, slides, and similar), sensors, ordata signals transmitted by any number of communication devices,computers, smart surgical devices, and imaging systems. The controller136010 may be composed of any type or types of computer processordevices, one or more memory components (static and/or dynamic memorycomponents), and communication components configured to transmit and/orreceive data signals (analog or digital) as may be required for thefunctioning of the controller. The memory components of the controller136010 may contain one or more instructions that, when read by the oneor more computer processor devices, may direct the operation of thecontroller. Examples of such instructions and their intended results aredisclosed below.

Electrical energy may be sourced by the electrical generator 136012 andreceived by a surgical instrument 136015 such as an active monopolarelectrode. In some aspects, the active electrode may be in electricalcommunication with an electrical source terminal of the electricalgenerator 136012 to receive the electrical energy. In some aspects, thesurgical instrument 136015 may receive an electrical signal over a firstconducting electrical path 136017 such as a wire or other cabling.

During the procedure, the patient 136027 may lie supine on a return pad136020. The return pad 136020 may be in electrical communication withthe electrical generator 136012 via an electrical return terminal, andthe electrical energy sourced into the patient 136027 by theelectrosurgical instrument 136015, such as an active electrode, may bereturned to the electrical generator 136012 through the return pad136020. In some aspects, the return pad 136020 may be in electricalcommunication with the electrical return terminal over a secondconducting electrical path 136023, such as a wire or other cabling.

In some aspects, the generator 136012 may supply alternating current atradiofrequency levels to the electrosurgical instrument 136015. In somealternative aspects, the electrosurgical instrument 136015 may alsoincorporate features for ultrasonic therapeutic modes, and the generator136012 may also be configured to generate power to drive one or moreultrasonic therapeutic components. The electrosurgical instrument136015, which typically includes an electrode tip (i.e., an activeelectrode) which can be positioned at a target tissue of a patient136027, receives the alternating current from the generator 136012 anddelivers the alternating current to the target tissue via the electrodetip. The alternating current received by the electrode tip may be fromthe generator 136012 via a first conducting electrical path 136017. Thealternating current is received at the target tissue, and the resistancefrom the tissue creates heat which provides the desired effect (e.g.,sealing and/or cutting) at the surgical site. The alternating currentreceived at the target tissue is conducted through the patient's bodyand ultimately is received by the one or more return electrodes of thereturn pad 136020. The alternating current received by the return pad136020 may be conducted back to the generator via a second conductingelectrical path 136023 to complete the closed path followed by thealternating current. The one or more return electrodes are configured tocarry the amount of current introduced by the electrode tip. The returnpad 136020 may be attached to the patient's body or may be separated asmall distance from the patient's body (i.e., capacitive coupling). Thealternating current received by the one or more return electrodes ispassed back to the generator 136012 to complete the closed path followedby the alternating current.

For an electrosurgical system 136000 which utilizes capacitive couplingto complete the current path between the patient's body and the returnelectrode, the patient's body effectively acts as a first capacitiveplate of a capacitor and the return electrode pad effectively acts as asecond capacitive plate of a capacitor.

In some aspects, the return pad 136020 may include a single returnelectrode which incorporates an array of multiple sensing devices. Insome alternative aspects, the return pad 136020 may include an array ofreturn electrodes, where an array of sensing devices may be incorporatedinto the array of return electrodes. In one non-limiting example, thereturn pad 136020 may include multiple return electrodes in which eachof the return electrodes includes a sensing device.

By incorporating an array of sensing devices into the return electrodepad 136020, the sensing devices may be used to detect either a nervecontrol signal applied to the patient or a movement of an anatomicalfeature of the patient resulting from an application of the nervecontrol signal. The sensing devices may include, without limitation, oneor more pressure sensors, one or more accelerometers, or combinationsthereof. In some non-limiting aspects, a sensing device may beconfigured to output a signal indicative of the detected nerve controlsignal and/or the detected movement of an anatomical feature of thepatient. Using Coulomb's law and the respective locations of the activeelectrode, the patient's body and the sensing devices, the detectednerve control signal and/or movement of an anatomical feature of thepatient can be analyzed to determine the location of a nerve within thepatient's body.

In some aspects, for example as depicted in FIG. 32, a return pad 136120may include a plurality of electrodes 136125 which can be capacitivelycoupled to the patient's body and collectively are configured to carrythe amount of current introduced into the patient's body by theelectrosurgical instrument. For this capacitive coupling, the patient'sbody effectively acts as one plate of a capacitor and collectively theplurality of electrodes 136125 of the return pad 136120 effectively acttogether as the other plate of the capacitor. A more detaileddescription of capacitive coupling can be found, for example, in U.S.Pat. No. 6,214,000, titled CAPACITIVE REUSABLE ELECTROSURGICAL RETURNELECTRODE, issued Apr. 10, 2001 and in U.S. Pat. No. 6,582,424, titledCAPACITIVE REUSABLE ELECTROSURGICAL RETURN ELECTRODE, issued Jun. 24,2003, the entire contents of which are each incorporated herein byreference and in their respective entireties.

FIG. 31 illustrates a plurality of electrodes 136125 a-d of the returnpad of FIG. 30, in accordance with at least one aspect of the presentdisclosure. Although four electrodes 136215 a-d are shown in FIG. 31, itwill be appreciated that the return pad 136120 may include any number ofelectrodes 136125. For example, according to various aspects, the returnpad 136120 may include two electrodes, eight electrodes, sixteenelectrodes, or any number of electrodes that may be fabricated in thereturn pad 136120. It should be recognized that the number of electrodesmay be an even integer or an odd integer. Also, although the individualelectrodes 136125 a-d are shown in FIG. 31 as being substantiallyrectangular, it will be appreciated that the individual electrodes canbe of any suitable shape.

The electrodes 136125 a-d of the return pad 136120 may serve as thereturn electrodes of the electrosurgical system of FIGS. 30 and 31, andcan also be considered to be segmented electrodes as the electrodes136125 a-d can be selectively decoupled from the patient's body and/orthe generator. In some aspects, the electrodes 136125 a-d of the returnpad 136120 can be coupled together to effectively act as one largeelectrode. For example, according to various aspects, each of theelectrodes 136125 a-d of the return pad 136120 can be connected byrespective conductive members 136130 a-d to inputs of a switching device136135 as shown in FIG. 32. When the switching device 136135 is in anopen position, as shown in FIG. 32, the respective electrodes 136125 a-dof the return pad 136120 are decoupled from one another as well as fromthe patient's body and/or the generator. In contrast, when the switchingdevice 136135 is in a closed position, the respective electrodes 136125a-d of the return pad 136120 are coupled together to effectively act asa single large electrode. It may be recognized that differingcombinations of electrodes 136125 a-d may be coupled together by theswitching device 136135 to form any group or groups of electrodes. Forexample, if a patient is disposed in a supine position on the return pad136120 with the patient's head proximate to the switching device 136135,electrodes 136125 a and 136125 c may be coupled together and electrodes136125 b and 136125 d may be coupled together thereby sensing electricalcurrents flowing through the lower torso and upper torso, respectively.Alternatively, if a patient is disposed in a supine position on thereturn pad 136120 with the patient's head proximate to the switchingdevice 136135, electrodes 136125 a and 136125 b may be coupled togetherand electrodes 136125 c and 136125 d may be coupled together therebysensing electrical currents flowing through the right torso and lefttorso, respectively.

The switching device 136135 can be controlled by a processing circuit(e.g., a processing circuit of the generator of the electrosurgicalsystem, of a hub of an electrosurgical system, etc.). For purposes ofsimplicity, the processing circuit is not shown in FIG. 32. According tovarious aspects, the switching device 136135 can be incorporated intothe return pad 136120. According to other aspects, the switching device136135 can be incorporated into the second conducting electrical path ofthe electrosurgical system of FIGS. 30 and 31. The return pad 136120 canalso include a plurality of sensing devices.

FIG. 33 illustrates an array of sensing devices 136140 a-d of the returnpad in accordance with at least one aspect of the present disclosure.According to various aspects, the number of sensing devices 136140 a-dmay correspond to the number of electrodes 136125 a-d such that there isone sensing device for each electrode (for example, sensing device136140 a with electrode 136125 a, sensing device 136140 b with electrode136125 b, sensing device 136140 c with electrode 136125 c, and sensingdevice 136140 d with electrode 136125 d). Each sensing device 136140 a-dmay be mounted to or integrated with a corresponding electrode 136125a-d, respectively. However, although the number of sensing devices136140 a-d associated with the corresponding electrodes 136125 a-d maycorrespond to the number of electrodes, it will be appreciated that thereturn pad may include any number of sensing devices. For example, foraspects of the return pad which include sixteen electrodes, the returnpad may only include four or eight sensing devices. Although the sensingdevices 136140 a-d are shown in FIG. 33 as being centered on thecorresponding electrodes 136125 a-d, respectively, it will beappreciated that the sensing devices 136140 a-d can be positioned on anyportion of the corresponding electrodes 136125 a-d. It may be furtherunderstood that the position of a particular sensing device on aparticular electrode is independent of a position of any other sensingdevice on its respective electrode.

The sensing devices 136140 a-d are configured to detect a monopolarnerve control signal applied to the patient and/or a movement of ananatomical feature of the patient (e.g., a muscle twitch) resulting fromapplication of the nerve control signal. The monopolar nerve controlsignal may be applied by the surgical instrument of the electrosurgicalsystem of FIGS. 30 and 31, or may be applied by a different surgicalinstrument which is coupled to a different generator. Each sensingdevice 136140 a-d may include, for example, a pressure sensor, anaccelerometer, or combinations thereof, and is configured to output asignal indicative of the detected nerve control signal and/or thedetected movement of an anatomical feature of the patient. In somenon-limiting examples, a sensing device composed of a pressure sensormay include for example, a piezoresistive strain gauge, a capacitivepressure sensor, an electromagnetic pressure sensor, and/or apiezoelectric pressure sensor either alone or in combination. In somenon-limiting examples, a sensing device composed of an accelerometer mayinclude, for example, a mechanical accelerometer, a capacitiveaccelerometer, a piezoelectric accelerometer, an electromagneticaccelerometer, and/or a microelectromechanical system (MEMS)accelerometer either alone or in combination. The respective outputsignals of the respective sensing devices 136140 a-d may be in the formof analog signals and/or digital signals.

Using Coulomb's law and the respective locations of the active electrodeof the surgical instrument, the patient's body and the respectivesensing devices, the respective output signals of the respected sensingdevices 136140 a-d, which are indicative of a detected nerve controlsignal and/or movement of an anatomical feature of the patient, can beanalyzed to determine the location of a nerve within the patient's body.Coulomb's law states that E=K(Q/r²), where E is the threshold currentrequired at a nerve to stimulate the nerve, K is a constant, Q is theminimal current from the nerve stimulation electrode and r is thedistance from the nerve. The further the nerve stimulation electrode isfrom the nerve (r increases), the current required to stimulate thenerve is proportionately greater. Thus, the amount of stimulation of anexcitable tissue as measured by a sensing device 136150 a-d may berelated to the distance of the nerve stimulation electrode to theexcitable tissue at constant current stimulation. In some aspects, anoutput signal of a sensing device 136140 a-d may also be dependent onthe distance of the excitable tissue to the sensing device 136140 a-d.It may be recognized that multiple sensing devices 136140 a-d may beused to triangulate the position of an electrically stimulated excitabletissue based on the geometry and position of the multiple sensingdevices 136140 a-d. A constant current stimulus can thus be utilized toestimate the distance from the nerve stimulation electrode to the nerve.Alternatively, current stimulus composed of varying amounts of currentmay be used to improve the determination of the position of theexcitable tissue through the triangulation method associated withmultiple sensing devices 136140 a-d. In general, the respectivestrengths of the output signals of the respective sensing devices areindicative of how close or far the respective sensing devices are fromthe stimulated nerve of the patient.

According to various aspects, the analysis of the respective outputsignals of the respective sensing devices can be performed by aprocessing circuit of the generator of the electrosurgical system ofFIGS. 30 and 31, by a processing circuit of a nerve monitoring systemwhich is separate from the generator of the electrosurgical systemthereof, by a processing circuit of a hub of an electrosurgical system,etc. The analysis can be performed in real time or in near-real time.According to various aspects, the respective output signals serve asinputs to a monopolar nerve stimulation algorithm which is executed bythe processing circuit.

As shown in FIG. 33, according to various aspects, the output signals ofthe respective sensing devices 136140 a-d can be input into a multipleinput-single output switching device 136137 (e.g., a multiplexer) viarespective conductive members 136142 a-d, respectively. By controllingthe selection signals S0, S1 to the multiple input-single outputswitching device 136137, the multiple input-single output switchingdevice 136137 can be controlled to output only one of the output signalsof the respective sensing devices 136140 a-d at a time for theabove-described analysis. As one non-limiting example, with reference toFIG. 33, by setting the selection signals S0, S1 to 0,0, the outputsignal from the sensing device 136140 c can be output by the multipleinput-single output switching device 136137 for analysis by theapplicable processing circuit. In another non-limiting example, settingthe selection signals S0, S1 to 0,1, the output signal from the sensingdevice 136140 a can be output by the multiple input-single outputswitching device 136137 for analysis by the applicable processingcircuit. Similarly, by setting the selection signals S0, S1 to 1,0, theoutput signal from the sensing device 136140 d can be output by themultiple input-single output switching device 136137 for analysis by theapplicable processing circuit. And, by extension, by setting theselection signals S0, S1 to 1,1, the output signal from the sensingdevice 136140 b can be output by the multiple input-single outputswitching device 136137 for analysis by the applicable processingcircuit.

The selection signals S0, S1 can be provided to the multipleinput-single output switching device 136137 by a processing circuit suchas, as non-limiting examples, a processing circuit of the generator ofthe electrosurgical system of FIGS. 30 and 31, a processing circuit of anerve monitoring system which is separate from the generator of theelectrosurgical system, by a processing circuit of a hub of anelectrosurgical system, and similar. For purposes of simplicity, theprocessing circuit is not shown in FIG. 33. By providing the variousselection signals at a fast enough rate, the output signals of therespective sensing devices 136125 a-d can effectively be scanned at arate which allows for the timely analysis of all of the output signalsof the respective sensing devices 136125 a-d to determine the positionof the stimulated nerve.

According to various aspects, the multiple input-single output switchingdevice 136137 can be incorporated into the return pad. According toother aspects, the multiple input-single output switching device 136137can be incorporated into the second conducting electrical path 136023 ofthe electrosurgical system 136000 of FIG. 30.

The control of the multiple input-single output switching device 136137as disclosed in FIG. 33 may be in the context of a four input-one outputswitching device, corresponding to the four sensing devices 136140 a-ddepicted in FIG. 33. It will be appreciated that for aspects in whichthere are more than four sensing devices (e.g., sixteen sensingdevices), the output signals of the more than more than four sensingdevices may serve as inputs to a multiple input-single output switchingdevice having more than two selection signals (e.g., S0, S1, S2 and S3).

For aspects where the output signals of the sensing devices (for example136140 a-d are analog signals, the output of the multiple input-singleoutput switching device 136137 can be converted into a correspondingdigital signal by an analog-to-digital converter 136145 prior to theperformance of the analysis of the output signals by the applicableprocessing circuit.

Returning to FIG. 30, according to various aspects, the detection of thenerve control signal and/or the movement of an anatomical feature of thepatient by the sensing devices can be performed while the electrodes136125 a-d of the return pad 136120 are coupled to one another or whilethe electrodes 136125 a-d are uncoupled from one another. For example,with regard to performing the detection when the respective electrodes136125 a-d of the return pad 136120 are uncoupled from one another,after positioning the patient on the operating table but before startinga surgical procedure, the return pad 136120 can be placed in a “sensingmode” by controlling the switching device 136135 to uncouple therespective electrodes 136125 a-d of the return pad 136120 from oneanother. While the respective electrodes 136125 a-d are uncoupled fromone another, a nerve and/or a nerve bundle can be stimulated with anelectrosurgical instrument as described above, and the respective outputsignals of the sensing devices of the return pad 136120 can be analyzedas described above to identify where the nerve, nerve bundle and/ornerve nexuses associated therewith are located. The locations of thenerve, nerve bundle and/or nerve nexuses may be input into a monopolarnerve stimulation algorithm profile. Once the locations of the nerve,nerve bundle and/or nerve nexuses are input into the monopolar nervestimulation algorithm profile, the locations of the nerve, nerve bundleand/or nerve nexuses may be effectively isolated from the capacitiveoperation of the electrodes of the return pad 136120. The locations ofthe nerve, nerve bundle and/or nerve nexuses may be used as sensingnodes of the monopolar nerve stimulation algorithm profile to inform thesurgeon as the surgeon approaches a nerve and/or a nerve bundle whileperforming a tissue cutting procedure. According to various aspects, thesurgeon may be informed of the nearby location of the nerve and/or nervebundle via an audible warning, a visual warning, a tactile (such asvibratory) warning, etc.

Returning to FIG. 31, with regard to performing the detection when therespective electrodes of the return pad 136015 are coupled with oneanother, according to various aspects, the generator 136012 of theelectrosurgical system can generate a high frequency waveform (thealternating current at radio frequency) which may be modulated on acarrier wave having a sufficiently low frequency to stimulate a nerve ofthe patient. This modulation may allow for the sensing of the nervecontrol signal and/or the movement of an anatomical feature concurrentlywith the capacitive coupling of the respective electrodes of the returnpad 136020 with the patient's body 136027. By applying a specificwaveform to the patient 136027 and sensing a specific response, there isa high level of confidence that the movement of the anatomical featuremay be correlated with the applied waveform and not due to randompatient motion. The modulation can be adjusted over time to stimulatedifferent nerve sizes. According to various aspects, the modulation canbe varied in amplitude over time in order to allow the applicableprocessing circuit to determine the distance the nerve and/or nervebundle is from the signal without having to constantly stimulate thenerve and/or nerve bundle.

The electrical energy applied by a surgical probe of an electrosurgicaldevice to the tissue may be in the form of radio frequency (RF) energythat may be in a frequency range described in EN60601-2-2:2009+A11:2011, Definition 201.3.218—HIGH FREQUENCY. Forexample, the frequencies in monopolar RF applications are typicallyrestricted to less than 5 MHz. Frequencies above 200 kHz can betypically used for MONOPOLAR applications in order to avoid the unwantedstimulation of nerves and muscles which would result from the use of lowfrequency current. Lower frequencies may be used for BIPOLAR techniquesif the RISK ANALYSIS shows the possibility of neuromuscular stimulationhas been mitigated to an acceptable level. Normally, frequencies above 5MHz are not used in order to minimize the problems associated with HIGHFREQUENCY LEAKAGE CURRENTS. However, higher frequencies may be used inthe case of BIPOLAR techniques. It is generally recognized that 10 mA isthe lower threshold of thermal effects on tissue.

It may be recognized that an electrosurgical device may take advantageof the response of excitable tissue to electrical frequencies below 200kHz in order to determine if such excitable tissue is sufficientlyproximate to the end effector of the electrosurgical device to bepotentially damaged thereby. FIG. 34 illustrates an RF signal 136210that may be used in an electrosurgical device to cut or cauterizetissue. Such an RF signal 136210 may be termed a therapeutic signalbecause it has a frequency that may effect a therapeutic result such ascauterizing or cutting tissue. For purely illustrative purposes, thex-axis may represent time wherein each division represents 10 μsecs, andthe y-axis (amplitude) has an arbitrary value. The RF signal 136210depicted in FIG. 34 may therefore have a frequency of about 1 MHz. Itmay be understood that an RF therapeutic signal may have any frequency,amplitude, and/or phase characteristics sufficient to effect atherapeutic application such as sealing, cauterizing, ablating, orcutting a tissue.

FIG. 35 depicts a signal 136220 that may be used to stimulate excitabletissue such as nerves or muscle. Again, solely for illustrativepurposes, the signal 136220 depicted in FIG. 35 may extend over about 20μsecs, and, if repeated, would constitute a waveform having a frequencyof about 50 kHz. Such an electrical signal 136220 may be termed astimulating signal because it has a frequency that may simulateexcitable tissues such as nerve or muscle tissue. It may be understoodthat a waveform of a stimulating signal may differ from the signal136220 presented in FIG. 35 in any aspect such as duration, frequency,or amplitude. In general, a stimulating signal 136220 may have anyappropriate waveform or amplitude while having a frequency within arange that is capable of stimulating such excitable tissue. Asindicated, such waveforms as depicted in FIGS. 34 and 35 areillustrative only. In one alternative example, a therapeutic RF signalmay have a frequency of about 330 kHz and a waveform to stimulateexcitable tissue may have a frequency of about 2 kHz.

It may be understood that an intelligent electrosurgical device may beconfigured to emit either a therapeutic signal or a stimulating signalor a combination thereof. FIGS. 36A-36C present examples of combinationsof therapeutic signals and stimulating signals. The electrical generatormay source an output current composed of any number or combination ofcharacteristics of the therapeutic signal and characteristics of atissue stimulating signal. Non-limiting examples of characteristics of atherapeutic signal may include a therapeutic signal frequency, atherapeutic signal amplitude, and a therapeutic signal phase.Non-limiting examples of characteristics of a tissue stimulating signalmay include a stimulating signal frequency, a stimulating signalamplitude, and a stimulating signal phase. It may be recognized that atherapeutic signal may be characterized by any number of frequencies,phases, and amplitudes. Additionally, it may be recognized that a tissuestimulating signal may be characterized by any number of frequencies,phases, and amplitudes. In some aspects, the controller may beconfigured to control an electrical generator to provide an electricaloutput composed of a combination or combinations of characteristics of atherapeutic signal and characteristics of a tissue stimulating signal.

FIG. 36A depicts a non-limiting example of a first combination signal136230 composed of a first therapeutic signal 136212 a, a stimulatingsignal 136222, and a second therapeutic signal 136212 b. As depicted,one or more stimulating signals (such as signal 136220, FIG. 35) mayalternate with one or more therapeutic signals (such as signal 136210,FIG. 34). It may be understood that the length of time for theapplication of the one or more therapeutic signals (such as 136212 a,b)may be arbitrary and may depend on the length of time that a medicalprofessional may wish to apply it. It may also be understood that thestimulating signal 136222 may be transmitted at any time during theapplication of a therapeutic signal. It may be further understood thatone or more zero-amplitude signals may be interspersed between one ormore therapeutic signals and one or more stimulating signals. Multiplestimulating signals may be transmitted in succession before a subsequenttherapeutic signal is transmitted.

FIG. 36B presents a non-limiting example of a second combination signal136240 of a therapeutic signal and a stimulating signal. In FIG. 36B,the stimulating signal (136220 depicted in FIG. 35) may be used tomodulate the amplitude of the therapeutic signal (136210 depicted inFIG. 34). In some aspects, the stimulating signal 136220 may be applieddirectly to an amplitude modulation circuit to modulate the amplitude ofa therapeutic signal 136210. In alternative aspects, the stimulatingsignal 136220 may be offset and scaled before being used to modulate theamplitude of the therapeutic signal 136210. As an example, thestimulating signal 136220 in FIG. 35 may be offset by +4.5 V and theresulting signal may be scaled by 4.5 V so that the amplitude of thetherapeutic signal 136210 is modulated by a positive-valued modulationsignal that may range in value from about 0.1V to about 2V. One mayreadily recognize that any simple transformation of a stimulating signal136220 may be used to modulate the amplitude of a therapeutic signal136210. It may be recognized that the amplitude of the therapeuticsignal 136210 may be modulated by the stimulating signal 136220 at anytime or for any number of times during the application of thetherapeutic signal. The amplitude of the therapeutic signal 136210 maybe modulated in the same manner over the course of multiple periods ofmodulation. Alternative, each amplitude modulation may differ accordingto the offset and/or scaling transformation of the stimulating signal136220.

FIG. 36C presents a non-limiting example of a third combination signal136250 of a therapeutic signal and a stimulating signal. In FIG. 36C thestimulating signal (136220 depicted in FIG. 35) may be used as a DCoffset to the therapeutic signal (136210 depicted in FIG. 34). It may berecognized that the stimulating signal 136220 may also be alteredaccording to any offset or scaling transformation before being appliedas a DC offset to the therapeutic signal 136210. It may be recognizedthat a DC offset based on the stimulating signal 136220 may be appliedat any time to the therapeutic signal 136210 and may be applied multipletimes over the course of the application of the therapeutic signal136210. The DC offset applied to the therapeutic signal 136210 may bethe same over the course of multiple periods of offset application.Alternative, each DC offset to the therapeutic signal 136210 may differaccording to the offset and/or scaling transformation of the stimulatingsignal

It may be understood that the combination of a stimulating signal with atherapeutic signal is not limited to the examples disclosed above anddepicted in FIGS. 36A-36C. A stimulating signal may be combined with atherapeutic signal in the same manner throughout an electrosurgicalprocedure. Alternatively, a stimulating signal may be combined with atherapeutic signal in any of a number of different ways throughout theelectrosurgical procedure. In some aspects, a stimulating signal may becombined with a therapeutic signal based on a choice made by a healthcare professional during the electrosurgical procedure. For example, thesurgical probe may include one or more controls to permit the operatorof the electrosurgical device to choose a mode of combination of thestimulating signal with the therapeutic signal. The surgical probe mayalso include one or more controls to permit the operator of theelectrosurgical device to choose when the stimulating signal may beapplied. In some alternative aspects, the surgical probe may includecontrols to permit a user to vary one or more characteristics of thetherapeutic signal and/or the stimulating signal. Non-limiting examplesof such signal characteristics may include one or more frequencies, oneor more phases, and one or more amplitudes. In some alternative aspects,the control or controls of the stimulating signal and the therapeuticsignal, their respective characteristics, or their combination may belocated on the control unit of the electrosurgical device, or may beincorporated in a foot-operated controller.

In some aspects, a smart electrosurgical device may include a processor,memory components, and instructions resident in the memory componentsfor adjusting a therapeutic signal output based on a distance of theactive electrode from excitable tissues. In some aspects, suchprocessor, memory components, and instructions may form components ofthe controller. In some aspects, such processor, memory components, andinstructions may form components of the electrical generator. In someaspects, such processor, memory components, and instructions may formcomponents of a computer system separate from the smart electrosurgicaldevice.

FIG. 37 summarizes a one non-limiting method 136300 in which such acontrol may be effected. A controller may configure a generator tocombine 136310 a stimulating signal with a therapeutic signal to form anelectrode emitted signal. The controller may then cause an electrode totransmit 136320 the electrode emitted signal from an active electrodeinto a patient tissue. The controller may then receive 136330 a signalfrom a return signal pad in electrical communication with at least aportion of the patient. The signal returned by the return signal pad mayinclude a signal generated by any one or more sensing devices disposedwithin the return pad. The controller may analyze 136340 the returnsignal from the return signal pad. It may be recognized that theanalysis 136340 may include any one or more pre-processing methodsincluding, without limitation, noise filtering, signal extraction,baseline adjustment, or any other method that may permit the controllerto identify the return signal from the patient. Based on the returnsignal or any suitable manipulation of the return signal, the controllermay determine 136350 that an excitable tissue has been stimulated by theemitted electrode signal. When the controller has determined 136350 thatan excitable tissue has been stimulated by the emitted electrode signal,the controller may determine 136360 a distance of the excitable tissuefrom the active electrode. The controller may then adjust 136370 anamplitude of the therapeutic signal when the distance of the excitabletissue from the active electrode is less than a threshold value. In someaspects, the threshold value may be determined by a user of theelectrosurgical system. In some other aspects, the threshold value maybe based on a plurality of data acquired by the electrosurgical systemor a HUB system of which the electrosurgical system is a part. In someaspects, the threshold value may be based on one or more mathematicalmodels, physiological models (such as animal models), or on dataacquired during an electrosurgical procedure on the patient.

In some further aspects, a smart electrosurgical device may includeprocessor readable instructions within a memory component that, whenexecuted by a processor, may cause the processor associated with acontrol unit to combine a stimulating signal with a therapeutic signal.Such instructions may include, without limitation: determining the typeof stimulating signal (for example, amplitude, duration, and waveform);determining the type of signal combination (for example alternating,amplitude modulation, DC offset, or other type of combination);determining the timing of the signal combination (that is, when, duringa therapeutic activity, the therapeutic signal and the stimulatingsignals are combined, for example periodically, randomly, or at a singletime); or determining types of signal transformations of the stimulatingsignal before being combined with the therapeutic signal.

In some aspects, the smart electrosurgical device may include processorreadable instructions stored within a memory component that, whenexecuted by a processor, may cause the processor within the control unitto cause an active monopolar electrode to emit a therapeutic signal, acombined therapeutic signal and stimulating signal, or a stimulatingsignal upon contact with a patient's tissue. In some aspects, the smartelectrosurgical device may include processor readable instructionswithin a memory component that, when executed by a processor, may causethe processor within the control unit to combine a therapeutic signaland a stimulating signal, to form an electrode emitted signal and totransmit the emitted signal from the active electrode into a patienttissue. In some aspects, the smart electrosurgical device may includeprocessor readable instructions within a memory component that, whenexecuted by a processor, may cause the processor within the control unitto receive one or more return signals from the patient, the returnsignals comprising electrical current returned from the current emittedby the active monopolar electrode and received by a return signal pad.In some aspects, the smart electrosurgical device may include processorreadable instructions within a memory component that, when executed by aprocessor, may cause the processor within the control unit to receiveone or more output signals of the one or more sensing devices associatedwith a return pad in contact with the patient. In some aspects, thesmart electrosurgical device may include processor readable instructionswithin a memory component that, when executed by a processor, may causethe processor within the control unit to analyze the one or more outputsignals received from the one or more sensing devices associated with areturn pad in contact with the patient.

In some aspects, the smart electrosurgical device may include processorreadable instructions within a memory component that, when executed by aprocessor, may cause the processor within the control unit to determinethat an excitable tissue had been stimulated by the stimulating signal.In some examples, the one or more sensing devices may include anaccelerometer associated with the return pad. In one non-limitingexample, an output of an accelerometer may reflect to motion of a musclein contact therewith which is activated by the stimulating signal. Theamount of muscle motion may result at least in part from the amount ofstimulating current received by either the muscle tissue or a nerveenervating the muscle. Because tissue may act as a resistive element tothe propagation of the stimulating signal, the amount of muscleactivation may indicate a distance of the active electrode from eitherthe muscle or the enervating nerves.

In some aspects, the patient may rest in a supine position on the returnpad, and the sensor outputs of the return pad, such as one or moreaccelerometers, may indicate an amount of muscle motion of a patient'sback muscles in contact with the return pad. In an alternative aspect, areturn pad may be placed on a muscle or muscle group proximal to theposition of the surgical site wherein the electrosurgical device may beoperated. In some examples, the return pad may be place on a portion ofsuperficial abdominal muscles (such as the rectus abdominis muscles) foran abdominal surgery. In some examples, the return pad may be placed ona side portion of the abdomen to monitor stimulation of the externaloblique or the anterior serratus muscles.

In some aspects, the smart electrosurgical device may include processorreadable instructions within a memory component that, when executed by aprocessor, may cause the processor within the control unit to calculateor determine a distance of an excitable tissue from a distal end of theactive electrode based at least in part on a return signal or one ormore output signals from the one or more sensing devices associated witha return pad in contact with the patient. In some aspects, the smartelectrosurgical device may include processor readable instructionswithin a memory component that, when executed by a processor, may causethe processor within the control unit to adjust one or more of anamplitude, a frequency, and a phase of a therapeutic signal based atleast in part on a distance of an excitable tissue from the distal endof the active electrode. In some aspects, the amplitude, frequency,and/or phase of a therapeutic signal may be adjusted when the distanceof an excitable tissue from the active electrode is less than a firstpre-determined value. In some aspects, adjusting the amplitude,frequency, or phase of a therapeutic signal may result in theelectrosurgical systems emitting no therapeutic signal when the distanceof an excitable tissue from the active electrode is less than a secondpre-determined value.

In some additional aspects, the active electrode of a surgical probe ofthe electrosurgical device may be applied to a tissue solely todetermine a distance of excitable tissue from the active electrode. Insuch a use, the medical professional using the device may operate itsolely in a stimulating mode, without applying therapeutic signals tothe active electrode. In a stimulating mode, the user of the device mayoperate one or more controls configured to ramp a characteristic of thestimulating signal to determine under which conditions an excitabletissues is stimulated thereby. For example, a user may operate controlsconfigured to ramp a voltage or current amplitude of the stimulatingsignal from a low value to a high value. When a signal is received froma sensor (for example, an accelerometer sensing muscle movement), theelectrosurgical device may then calculate an approximate distance fromthe active electrode to the excitable tissue based at least in part onthe amplitude of the stimulating signal. In another example, a user mayoperate controls configured to ramp a frequency of the stimulatingsignal from a low value to a high value. When a signal is received froma sensor (for example, an accelerometer sensing muscle movement), theelectrosurgical device may then calculate an approximate distance fromthe active electrode to the excitable tissue based at least in part onthe frequency of the stimulating signal.

In some aspects, an electrosurgical device or a smart electrosurgicaldevice may be incorporated into a surgical HUB system. The HUB systemmay incorporate a number of hand-held medical devices, robotic medicaldevices, image acquisition devices, image display devices, communicationdevices, processing devices, networking devices, and other electronicdevices that may operate in a concerted and coordinated fashion. In someaspects, the HUB may include such devices located within a singlesurgical suite, located within a plurality of surgical suites, orlocated within any number of computer server locations. The computermemory modules, instructions, and processors disclosed above in thecontext of the control of a smart, stand-alone electrosurgical devicemay be distributed among any of the components of the surgical HUBsystem as may be appropriate.

In some aspects, additional information that may be acquired by thecomponents of the surgical HUB system may be used to improve theoperation of a smart electrosurgical device. For example, cameras andimaging systems directed at a surgical site may provide imaginginformation that can be used to determine the location of the distal endof the active electrode with respect to tissue in the surgical site. Theimage-based location of the distal end of the active electrode may beused with the return pad sensor output to refine the distance betweenthe active electrode and any excitable tissue in the patient. In somealternative examples, the HUB system may include data comprisinganatomical models related to the location of nerve and muscle tissue.Such model information may also be used along with the image-basedlocalization of the active electrode and the return pad sensor output tobetter determine the proximity of the active electrode to knownexcitable tissue.

Although the functions and devices disclosed above may be related solelyto an electrosurgical device, it may be recognized that such functionsand deices may also be incorporated into multi-mode surgical devicesthat include functions associated with an electrosurgical device. Forexample, a multi-mode surgical device may incorporate featuresassociated with an electrosurgical device along with features associatedwith an ultrasonic surgical device. In addition to the functionsdisclosed above regarding altering the properties of an electrosurgicaltherapeutic signal, a multi-mode device may include other functions. Forexample, a surgical device may use either RF energy or ultrasound for atherapeutic effect, for example cutting a tissue. In such a multi-modedevice, RF energy may be initially applied to a tissue for purposes ofcutting material, but the multi-mode device may be configured to switchto an ultrasound mode if the end effector of the multi-mode device isdetermined to be too close to excitable tissue.

Situational Awareness

Referring now to FIG. 38, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206, for example, isdepicted. The timeline 5200 is an illustrative surgical procedure andthe contextual information that the surgical hub 106, 206 can derivefrom the data received from the data sources at each step in thesurgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step 5204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step 5206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step 5208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step 5210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step 5212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step 5214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step 5216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step 5204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step 5220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step 5224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 5224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step 5226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step 5228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filedDec. 28, 2017, which is herein incorporated by reference in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 102.

While several forms have been illustrated and described, it is not theintention of the applicant to restrict or limit the scope of theappended claims to such detail. Numerous modifications, variations,changes, substitutions, combinations, and equivalents to those forms maybe implemented and will occur to those skilled in the art withoutdeparting from the scope of the present disclosure. Moreover, thestructure of each element associated with the described forms can bealternatively described as a means for providing the function performedby the element. Also, where materials are disclosed for certaincomponents, other materials may be used. It is therefore to beunderstood that the foregoing description and the appended claims areintended to cover all such modifications, combinations, and variationsas falling within the scope of the disclosed forms. The appended claimsare intended to cover all such modifications, variations, changes,substitutions, modifications, and equivalents.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

Various aspects of the subject matter described herein are set out inthe following numbered examples.

Example 1

An electrosurgical device, comprising: a controller comprising anelectrical generator; a surgical probe comprising a distal activeelectrode, wherein the active electrode is in electrical communicationwith an electrical source terminal of the electrical generator; and areturn pad in electrical communication with an electrical returnterminal of the electrical generator, wherein the electrical generatoris configured to source an electrical current from the electrical sourceterminal, and wherein the electrical current sourced by the electricalgenerator combines characteristics of a therapeutic electrical signaland characteristics of an excitable tissue stimulating signal.

Example 2

The electrosurgical device of Example 1, wherein the therapeuticelectrical signal is a radiofrequency signal having a frequency greaterthan 200 kHz and less than 5 MHz.

Example 3

The electrosurgical device of any one or more of Examples 1 through 2,wherein the excitable tissue stimulating signal is an AC signal having afrequency less than 200 kHz.

Example 4

The electrosurgical device of any one or more of Examples 1 through 3,wherein the electrical current sourced by the electrical generatorcomprises at least one alternating therapeutic electrical signal and atleast one alternating excitable tissue stimulating signal.

Example 5

The electrosurgical device of any one or more of Examples 1 through 4,wherein the electrical current sourced by the electrical generatorcomprises a therapeutic electrical signal amplitude modulated by theexcitable tissue stimulating signal.

Example 6

The electrosurgical device of any one or more of Examples 1 through 5,wherein the electrical current sourced by the electrical generatorcomprises a therapeutic electrical signal DC offset by the excitabletissue stimulating signal.

Example 7

The electrosurgical device of any one or more of Examples 1 through 6,wherein the return pad further comprises at least one sensing devicehaving a sensing device output, and the sensing device is configured todetermine a stimulation of an excitable tissue by the excitable tissuestimulating signal.

Example 8

The electrosurgical device of Example 7, wherein the controller isconfigured to receive the sensing device output.

Example 9

The electrosurgical device of Example 8, wherein the controllercomprises a processor and at least one memory component in datacommunication with the processor, and wherein the at least one memorycomponent stores one or more instructions that, when executed by theprocessor, cause the processor to determine a distance of the activeelectrode from an excitable tissue based at least in part on the sensoroutput received by the controller.

Example 10

The electrosurgical device of Example 9, wherein the at least one memorycomponent stores one or more instructions that, when executed by theprocessor, cause the processor to alter a value of at least onecharacteristic of the therapeutic electrical signal when the distance ofthe active electrode from an excitable tissue is less than apredetermined value.

Example 11

An electrosurgical system comprising: a processor; and a memory coupledto the processor, the memory configured to store instructions executableby the processor to: cause an electrical generator to combine one ormore characteristics of a therapeutic signal with one or morecharacteristics of an excitable tissue stimulating signal to form acombination signal; cause the electrical generator to transmit thecombination signal into a tissue of a patient through an activeelectrode in physical contact with the patient; and receive a sensingdevice output signal from a sensing device disposed within a return padin physical contact with the patient.

Example 12

The electrosurgical system of Example 11, wherein the memory isconfigured to further store instructions executable by the processor to:determine, based at least in part on the sensing device output signal, adistance from the active electrode to an excitable tissue.

Example 13

The electrosurgical system of Example 12, wherein the memory isconfigured to further store instructions executable by the processor to:cause the controller to alter one or more characteristics of thetherapeutic signal when the distance from the active electrode to theexcitable tissue is less than a predetermined value.

Example 14

The electrosurgical system of any one or more of Examples 11-13, whereinthe instructions executable by the processor to cause an electricalgenerator to combine one or more characteristics of a therapeutic signalwith one or more characteristics of an excitable tissue stimulatingsignal to form a combination signal comprises instructions executable bythe processor to cause the electrical generator to alternate thetherapeutic signal and the excitable tissue stimulating signal.

Example 15

The electrosurgical system of any one or more of Examples 11-14, whereinthe instructions executable by the processor to cause an electricalgenerator to combine one or more characteristics of a therapeutic signalwith one or more characteristics of an excitable tissue stimulatingsignal to form a combination signal comprises instructions executable bythe processor to cause the electrical generator to modulate an amplitudeof the therapeutic signal by an amplitude of the excitable tissuestimulating signal.

Example 16

The electrosurgical system of any one or more of Examples 11-15, whereinthe instructions executable by the processor to cause an electricalgenerator to combine one or more characteristics of a therapeutic signalwith one or more characteristics of an excitable tissue stimulatingsignal to form a combination signal comprises instructions executable bythe processor to cause the electrical generator to offset a DC value ofthe therapeutic signal by an amplitude of the excitable tissuestimulating signal.

Example 17

An electrosurgical system comprising: a control circuit configured to:control an electrical output of an electrical generator, in which theelectrical output comprises one or more characteristics of a therapeuticsignal and one or more characteristics of an excitable tissuestimulating signal; receive a sensing device signal from at least onesensing device configured to measure an activity of an excitable tissueof a patient; determine a distance between a location of an activeelectrode configured to transmit the electrical output of the electricalgenerator into a patient tissue and a location of the at least onesensing device; and alter the electrical output of the electricalgenerator in at least one characteristic of the therapeutic signal whenthe distance between the location of the active electrode configured totransmit the electrical output of the electrical generator into thepatient tissue and the location of the at least one sensing device isless than a pre-determined value.

Example 18

The electrosurgical system of Example 17, wherein the control circuitconfigured to alter the electrical output of the electrical generator inat least one characteristic of the therapeutic signal when the distancebetween the location of the active electrode configured to transmit theelectrical output of the electrical generator into the patient tissueand the location of the at least one sensing device is less than apre-determined value comprises a control circuit configured to minimizethe at least one characteristic of the therapeutic signal.

Example 19

A non-transitory computer readable medium storing computer readableinstructions which, when executed, causes a machine to: control anelectrical output of an electrical generator, in which the electricaloutput comprises one or more characteristics of a therapeutic signal andone or more characteristics of an excitable tissue stimulating signal;receive a sensing device signal from at least one sensing deviceconfigured to measure an activity of an excitable tissue of a patient;determine a distance between a location of an active electrodeconfigured to transmit the electrical output of the electrical generatorinto a patient tissue and a location of the at least one sensing device;and alter the electrical output of the electrical generator in at leastone characteristic of the therapeutic signal when the distance betweenthe location of the active electrode configured to transmit theelectrical output of the electrical generator into the patient tissueand the location of the at least one sensing device is less than apre-determined value.

The invention claimed is:
 1. An electrosurgical device, comprising: acontroller comprising an electrical generator; a surgical probecomprising a distal active electrode, wherein the distal activeelectrode is in electrical communication with an electrical sourceterminal of the electrical generator; and a return pad in electricalcommunication with an electrical return terminal of the electricalgenerator, wherein the electrical generator is configured to source anelectrical current from the electrical source terminal, wherein theelectrical current sourced by the electrical generator combinescharacteristics of a therapeutic electrical signal and characteristicsof an excitable tissue stimulating signal, and wherein the controllerfurther comprises a processor and at least one memory component in datacommunication with the processor, wherein the at least one memorycomponent stores one or more instructions that, when executed by theprocessor, cause the processor to: determine a distance of the distalactive electrode from an excitable tissue; and alter a value of at leastone characteristic of the therapeutic electrical signal when thedistance of the distal active electrode from the excitable tissue isless than a predetermined value.
 2. The electrosurgical device of claim1, wherein the therapeutic electrical signal is a radiofrequency signalhaving a frequency greater than 200 kHz and less than 5 MHz.
 3. Theelectrosurgical device of claim 1, wherein the excitable tissuestimulating signal is an AC signal having a frequency less than 200 kHz.4. The electrosurgical device of claim 1, wherein the electrical currentsourced by the electrical generator comprises at least one alternatingtherapeutic electrical signal and at least one alternating excitabletissue stimulating signal.
 5. The electrosurgical device of claim 1,wherein the electrical current sourced by the electrical generatorcomprises a therapeutic electrical signal amplitude modulated by theexcitable tissue stimulating signal.
 6. The electrosurgical device ofclaim 1, wherein the electrical current sourced by the electricalgenerator comprises a therapeutic electrical signal DC offset by theexcitable tissue stimulating signal.
 7. The electrosurgical device ofclaim 1, wherein the return pad further comprises at least one sensingdevice having a sensing device output, and the at least one sensingdevice is configured to determine a stimulation of the excitable tissueby the excitable tissue stimulating signal.
 8. The electrosurgicaldevice of claim 7, wherein the controller is configured to receive thesensing device output.
 9. The electrosurgical device of claim 8, whereinthe distance of the distal active electrode from the excitable tissue isdetermined based at least in part on the sensing device output receivedby the controller.
 10. An electrosurgical system comprising: aprocessor; and a memory coupled to the processor, the memory configuredto store instructions executable by the processor to: cause anelectrical generator to combine one or more characteristics of atherapeutic signal with one or more characteristics of an excitabletissue stimulating signal to form a combination signal; cause theelectrical generator to transmit the combination signal into a tissue ofa patient through an active electrode in physical contact with thepatient; receive a sensing device output signal from a sensing devicedisposed within a return pad in physical contact with the patient;determine a distance from the active electrode to an excitable tissue;and cause an alteration of one or more characteristics of thetherapeutic signal when the distance from the active electrode to theexcitable tissue is less than a predetermined value.
 11. Theelectrosurgical system of claim 10, wherein the distance from the activeelectrode to the excitable tissue is determined based at least in parton the sensing device output signal.
 12. The electrosurgical system ofclaim 10, wherein the instructions executable by the processor to causethe electrical generator to combine the one or more characteristics ofthe therapeutic signal with the one or more characteristics of theexcitable tissue stimulating signal to form the combination signalcomprises instructions executable by the processor to cause theelectrical generator to modulate an amplitude of the therapeutic signalby an amplitude of the excitable tissue stimulating signal.
 13. Theelectrosurgical system of claim 10, wherein the instructions executableby the processor to cause the electrical generator to combine the one ormore characteristics of the therapeutic signal with the one or morecharacteristics of the excitable tissue stimulating signal to form thecombination signal comprises instructions executable by the processor tocause the electrical generator to offset a DC value of the therapeuticsignal by an amplitude of the excitable tissue stimulating signal. 14.An electrosurgical system comprising: a processor; and a memory coupledto the processor, the memory configured to store instructions executableby the processor to: cause an electrical generator to combine one ormore characteristics of a therapeutic signal with one or morecharacteristics of an excitable tissue stimulating signal to form acombination signal to cause the electrical generator to alternate thetherapeutic signal and the excitable tissue stimulating signal; causethe electrical generator to transmit the combination signal into atissue of a patient through an active electrode in physical contact withthe patient; and receive a sensing device output signal from a sensingdevice disposed within a return pad in physical contact with thepatient.
 15. An electrosurgical system comprising: a control circuitconfigured to: control an electrical output of an electrical generator,in which the electrical output comprises one or more characteristics ofa therapeutic signal and one or more characteristics of an excitabletissue stimulating signal; receive a sensing device signal from at leastone sensing device configured to measure an activity of an excitabletissue of a patient; determine a distance between a location of anactive electrode configured to transmit the electrical output of theelectrical generator into a patient tissue and a location of the atleast one sensing device; and alter the electrical output of theelectrical generator in at least one characteristic of the therapeuticsignal when the distance between the location of the active electrodeconfigured to transmit the electrical output of the electrical generatorinto the patient tissue and the location of the at least one sensingdevice is less than a pre-determined value.
 16. A non-transitorycomputer readable medium storing computer readable instructions which,when executed, causes a machine to: control an electrical output of anelectrical generator, in which the electrical output comprises one ormore characteristics of a therapeutic signal and one or morecharacteristics of an excitable tissue stimulating signal; receive asensing device signal from at least one sensing device configured tomeasure an activity of an excitable tissue of a patient; determine adistance between a location of an active electrode configured totransmit the electrical output of the electrical generator into apatient tissue and a location of the at least one sensing device; andalter the electrical output of the electrical generator in at least onecharacteristic of the therapeutic signal when the distance between thelocation of the active electrode configured to transmit the electricaloutput of the electrical generator into the patient tissue and thelocation of the at least one sensing device is less than apre-determined value.
 17. An electrosurgical system comprising: acontrol circuit configured to: control an electrical output of anelectrical generator, in which the electrical output comprises one ormore characteristics of a therapeutic signal and one or morecharacteristics of an excitable tissue stimulating signal; receive asensing device signal from a sensor configured to measure an activity ofan excitable tissue of a patient; determine a distance between alocation of an active electrode configured to transmit the electricaloutput of the electrical generator into a patient tissue and a locationof the sensor; and alter the electrical output of the electricalgenerator in at least one of the one or more characteristics of thetherapeutic signal based on a comparison of the distance between thelocation of the active electrode configured to transmit the electricaloutput of the electrical generator into the patient tissue and thelocation of the sensor to a predetermine value.
 18. An electrosurgicaldevice, comprising: a controller comprising an electrical generator; asurgical probe comprising a distal active electrode, wherein the distalactive electrode is in electrical communication with an electricalsource terminal of the electrical generator; and a return pad inelectrical communication with an electrical return terminal of theelectrical generator, wherein the electrical generator is configured tosource an electrical current from the electrical source terminal,wherein the electrical current sourced by the electrical generatorcombines characteristics of a therapeutic electrical signal andcharacteristics of an excitable tissue stimulating signal, and whereinthe controller further comprises a processor and at least one memorycomponent in data communication with the processor, wherein the at leastone memory component stores one or more instructions that, when executedby the processor, cause the processor to: determine a distance of thedistal active electrode from an excitable tissue; and alter a value ofat least one characteristic of the therapeutic electrical signal basedon a comparison between the distance of the distal active electrode fromthe excitable tissue and a predetermined value.
 19. The electrosurgicaldevice of claim 18, wherein the therapeutic electrical signal is aradiofrequency signal having a frequency greater than 200k Hz and lessthan 5 MHz.
 20. The electrosurgical device of claim 18, wherein theexcitable tissue stimulating signal is an AC signal having a frequencyless than 200 kHz.
 21. The electrosurgical device of claim 18, whereinthe electrical current sourced by the electrical generator comprises atleast one alternating therapeutic electrical signal and at least onealternating excitable tissue stimulating signal.
 22. The electrosurgicaldevice of claim 18, wherein the electrical current sourced by theelectrical generator comprises a therapeutic electrical signal amplitudemodulated by the excitable tissue stimulating signal.
 23. Theelectrosurgical device of claim 18, wherein the electrical currentsourced by the electrical generator comprises a therapeutic electricalsignal DC offset by the excitable tissue stimulating signal.
 24. Theelectrosurgical device of claim 18, wherein the return pad furthercomprises at least one sensing device having a sensing device output,and the at least one sensing device is configured to determine astimulation of the excitable tissue by the excitable tissue stimulatingsignal.
 25. The electrosurgical device of claim 24, wherein thecontroller is configured to receive the sensing device output.
 26. Theelectrosurgical device of claim 25, wherein the distance of the distalactive electrode from the excitable tissue is determined based at leastin part on the sensing device output received by the controller.